Destino Twist Steerable Guiding Sheath
Steerable Guiding Sheath, 15F GW Kit
13manufacturers in China registered for this device type
92catalogue numbers in this listing
14510(k) clearances naming this product code
37recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Cardiocycle Medical(Suzhou) Co., Ltd. | Suzhou | Jiangsu | Complaint-file establishment | 1 |
Showing 12 of 13. All 13 manufacturers in China registered for Introducer, Catheter
Record
| Listed by | Oscor Inc., United States |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K140406 |
| Record published | 2021-10-01 |
| Record revised | 2026-02-04 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 5 to 30 °C |
| Sizes | Lumen/inner diameter 2.2 to 13.8 mm; outer diameter 2.8 to 7.3 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DCT1707150 | Lumen/Inner Diameter 5.7 mm | In distribution |
| DST0856517 | Outer Diameter 4 mm | In distribution |
| DST0655509TD | Lumen/Inner Diameter 2.2 mm | In distribution |
| DCT1407150 | Dilator Usable Length 89 cm | In distribution |
| DCT1207139 | Sheath Usable Length 71 cm | In distribution |
| DST1207550 | Sheath Usable Length 75 cm | In distribution |
| DCT1507150GW | Sheath Overall Length 86 cm | In distribution |
| DST0654517 | Sheath Overall Length 60 cm | In distribution |
| DST1405550 | Lumen/Inner Diameter 4.8 mm | In distribution |
| DCT1207522 | Sheath Usable Length 75 cm | In distribution |
| DST1705525 | Sheath Usable Length 55 cm | In distribution |
| DST0656509TD | Sheath Overall Length 80 cm | In distribution |
| DCT1207122 | Outer Diameter 5.3 mm | In distribution |
| DST0705522 | Curve Length 22 mm | In distribution |
| DCT1407150GW | Lumen/Inner Diameter 4.8 mm | In distribution |
| DST0655507D2 | Soft Dilator Overall Length 82 cm | In distribution |
| DST0859022 | Curve Length 22 mm | In distribution |
| DST1207150 | Curve Length 50 mm | In distribution |
| DST1405525 | Outer Diameter 6.3 mm | In distribution |
| DST1207517 | Dilator Overall Length 97 cm | In distribution |
| DCT1707125GW | Curve Length 25 mm | In distribution |
| DCT1507125 | Sheath Usable Length 71 cm | In distribution |
| DST0654522 | Sheath Usable Length 45 cm | In distribution |
| DCT1407125GW | Sheath Usable Length 71 cm | In distribution |
| DST1207139 | Curve Length 39 mm | In distribution |
| DST0856717 | Sheath Overall Length 81 cm | In distribution |
| DST06510007D2 | Dilator Overall Length 120 cm | In distribution |
| DCT1407125NM | Lumen/Inner Diameter 4.8 mm | In distribution |
| DCT1707125 | Lumen/Inner Diameter 5.7 mm | In distribution |
| DST0654509TD | Sheath Overall Length 60 cm | In distribution |
| DST0856750 | Curve Length 50 mm | In distribution |
| DST0855522 | Sheath Usable Length 55 cm | In distribution |
| DST0656522 | Dilator Usable Length 83 cm | In distribution |
| DST0705509TD | Curve Length 9 mm | In distribution |
| DST0655522 | Dilator Usable Length 73 cm | In distribution |
| DST0854522 | Dilator Overall Length 65 cm | In distribution |
| DST0704522 | Curve Length 22 mm | In distribution |
| DST0857350 | Curve Length 50 mm | In distribution |
| DCT1707150GW | Sheath Usable Length 71 cm | In distribution |
| DCT1387139 | Sheath Overall Length 86 cm | In distribution |
| DST0855517 | Outer Diameter 4 mm | In distribution |
| DCT1607125 | Dilator Usable Length 89 cm | In distribution |
| DCT1357125 | Curve Length 25 mm | In distribution |
| DST0656509 | Dilator Usable Length 83 cm | In distribution |
| DST1387139 | Sheath Usable Length 71 cm | In distribution |
| DST0704509 | Dilator Usable Length 63 cm | In distribution |
| DST0706509 | Outer Diameter 3.2 mm | In distribution |
| DST0659009 | Curve Length 9 mm | In distribution |
| DST12010022 | Sheath Overall Length 115 cm | In distribution |
| DST0705517 | Sheath Usable Length 55 cm | In distribution |
| DCT1407125 | Dilator Usable Length 89 cm | In distribution |
| DST0856530 | Sheath Overall Length 80 cm | In distribution |
| DST1204522 | Curve Length 22 mm | In distribution |
| DST0706509TD | Outer Diameter 3.2 mm | In distribution |
| DCT1507125GW | Sheath Overall Length 86 cm | In distribution |
| DST1705550 | Curve Length 50 mm | In distribution |
| DST1207522 | Outer Diameter 5.3 mm | In distribution |
| DCT1207150 | Dilator Usable Length 89 cm | In distribution |
| DST0854517 | Lumen/Inner Diameter 2.8 mm | In distribution |
| DST1605525 | Dilator Usable Length 73 cm | In distribution |
| DST1505550 | Sheath Usable Length 55 cm | In distribution |
| DST1207122 | Dilator Usable Length 89 cm | In distribution |
| DST1209030 | Sheath Usable Length 90 cm | In distribution |
| DST1204022 | Dilator Overall Length 62 cm | In distribution |
| DST0705509 | Sheath Overall Length 70 cm | In distribution |
| DST1505525 | Sheath Usable Length 55 cm | In distribution |
| DST0706522 | Curve Length 22 mm | In distribution |
| DST1605550 | Sheath Usable Length 55 cm | In distribution |
| DST0704509TD | Lumen/Inner Diameter 2.4 mm | In distribution |
| DST0655517 | Curve Length 17 mm | In distribution |
| DST0707517 | Sheath Usable Length 75 cm | In distribution |
| DCT1607150GW | Sheath Overall Length 86 cm | In distribution |
| DST1357125NM | Sheath Usable Length 71 cm | In distribution |
| DST0856722 | Dilator Overall Length 87 cm | In distribution |
| DCT1607150 | Curve Length 50 mm | In distribution |
| DST0706517 | Dilator Overall Length 85 cm | In distribution |
| DST0857317 | Sheath Usable Length 73 cm | In distribution |
| DST0706530 | Outer Diameter 3.2 mm | In distribution |
| DST0859017 | Curve Length 17 mm | In distribution |
| DST12010035 | Outer Diameter 5.3 mm | In distribution |
| DST0857722 | Dilator Usable Length 94 cm | In distribution |
| DCT1507150 | Outer Diameter 6.6 mm | In distribution |
| DST12010039 | Dilator Overall Length 122 cm | In distribution |
| DST0655509 | Lumen/Inner Diameter 2.2 mm | In distribution |
| DST0856522 | Dilator Overall Length 85 cm | In distribution |
| DST0709009 | Sheath Overall Length 105 cm | In distribution |
| DCT1607125GW | Curve Length 25 mm | In distribution |
| DCT1207550 | Sheath Overall Length 90 cm | In distribution |
| DST0857322 | Dilator Overall Length 92 cm | In distribution |
| DST0654509 | Sheath Usable Length 45 cm | In distribution |
| DCT1357125NM | Curve Length 25 mm | In distribution |
| DST0704517 | Lumen/Inner Diameter 2.4 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demax | Beijing Demax Medical Technology Co., Ltd. | 2,841 |
| Arrow | Teleflex Medical LLC | 1,036 |
| Prelude IDeal™ | Merit Medical Systems, Inc. | 294 |
| Fast-Cath™ | St. Jude Medical | 213 |
| Flexor | Cook Incorporated | 182 |
| Prelude Ease™ | Merit Medical Systems, Inc. | 176 |
| Performer | Cook Incorporated | 174 |
| VSI | Teleflex Medical LLC | 154 |
| Peel-Away | Cook Incorporated | 153 |
| OptiSeal™ | Greatbatch Medical | 127 |
| Brilliant | Lepu Medical Technology (Beijing) Co., Ltd. | 122 |
| Super Sheath | Togo Medikit Co., Ltd. | 122 |
Showing 12 of 439. All products under Introducer, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210627 | 2021-06-03 |
| K151951 | 2015-09-22 |
| K140917 | 2014-07-09 |
| K140406 | 2014-04-17 |
| K130633 | 2014-02-13 |
| K122958 | 2012-12-13 |
| K122960 | 2012-12-13 |
| K122084 | 2012-08-29 |
| K120459 | 2012-06-29 |
| K101497 | 2010-10-20 |
| K090114 | 2009-06-04 |
| K073100 | 2007-11-30 |
| K890277 | 1989-03-10 |
| K831751 | 1983-10-20 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Oscor Inc. | 510(k) number | 2021-12-22 | Class II | Process control | There is potential for separation between the threaded hub and threaded cap at the proximal end of the device. | 549 units |
Recalls
3 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-06-10 | Class I | Device Design | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. | 32,934 units | |
| 2026-06-10 | Class I | Device Design | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. | 355 units | |
| 2026-06-10 | Class I | Device Design | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. | 1332 units | |
| 2021-03-10 | Class II | Under Investigation by firm | Potential for open seal on sterile product | 500 devices | 2023-08-08 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 34 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 21 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 61 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 124 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 8 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 255 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 215 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 11 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 26 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 1,729 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 87 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 991 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 70 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 59 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 45 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 16 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 21 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 991 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 76 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 22 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 186 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 55 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 74 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 156 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 566 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 20 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 30 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 1,269 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 33 | 2019-07-26 |
| 2016-10-05 | Class II | Nonconforming Material/Component | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | 110 | 2019-07-26 |
| 2008-07-03 | Not classified | Process design | Difficulty breaking the sheath hub and subsequently to peel the sheath off for Introducer Set, Adelante size 7F. | 396 | 2008-12-09 |
| 2005-09-13 | Not classified | Other | Sheath size is larger than dilator size causing insertion difficulties. | 6985 | 2012-07-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.