SafeSheath® II
Hemostatic Tear-away Introducer System with Infusion Side Port, 9F, 30 cm
13manufacturers in China registered for this device type
39catalogue 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) | K122084 |
| Record published | 2017-11-27 |
| Record revised | 2026-02-04 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 5 to 30 °C |
| Sizes | Needle gauge 18 G; lumen/inner diameter 3 mm |
| Distribution end date | 2020-04-08 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SS7 | Guidewire Length 50 cm | 5 | In distribution |
| SSL6 | Dilator Length 28.5 cm | 5 | In distribution |
| 667460-300 | Sheath Length 13 cm | 5 | In distribution |
| SSL105 | Guidewire Length 60 cm | 5 | In distribution |
| 667475-300 | Needle Gauge 18 G | 5 | In distribution |
| SS12 | Sheath Length 13 cm | 5 | In distribution |
| SSL11 | Needle Gauge 18 G | 5 | In distribution |
| 667469-300 | Needle Gauge 18 G | 5 | In distribution |
| 667470-300 | Guidewire Length 60 cm | 5 | In distribution |
| 667464-300 | Guidewire Length 50 cm | 5 | In distribution |
| SSL9 | Sheath Length 23 cm | 5 | In distribution |
| SSCL9 | Sheath Length 19.13 cm | 5 | In distribution |
| 667461-300 | Needle Gauge 18 G | 5 | In distribution |
| SS125 | Needle Gauge 18 G | 5 | In distribution |
| 667463-300 | Needle Gauge 18 G | 5 | In distribution |
| SSC9 | Sheath Length 15.32 cm | 5 | In distribution |
| SS10 | Dilator Length 19.5 cm | 5 | In distribution |
| SSL7 | Needle Gauge 18 G | 5 | In distribution |
| SS95 | Dilator Length 19.5 cm | 5 | In distribution |
| SSL8 | Needle Gauge 18 G | 5 | In distribution |
| SS85 | Dilator Length 19.5 cm | 5 | In distribution |
| SS105 | Sheath Length 13 cm | 5 | In distribution |
| 667472-300 | Dilator Length 28.5 cm | 5 | In distribution |
| 667467-300 | Needle Gauge 18 G | 5 | In distribution |
| 667465-300 | Needle Gauge 18 G | 5 | In distribution |
| SSL9030 | 10 | In distribution | |
| SS5 | Dilator Length 19.5 cm | 5 | In distribution |
| SS11 | Sheath Length 13 cm | 5 | In distribution |
| SSCL9 | Sheath Length 19.13 cm | 5 | In distribution |
| 667462-300 | Needle Gauge 18 G | 5 | In distribution |
| 667473-300 | Sheath Length 23 cm | 5 | In distribution |
| SS6 | Dilator Length 19.5 cm | 5 | In distribution |
| SS9 | Needle Gauge 18 G | 5 | In distribution |
| SSL10 | Sheath Length 23 cm | 5 | In distribution |
| 667466-300 | Guidewire Length 50 cm | 5 | In distribution |
| SSL9040 | 10 | In distribution | |
| SS8 | Dilator Length 19.5 cm | 5 | In distribution |
| SSC9 | Sheath Length 15.32 cm | 5 | Withdrawn |
| SSCL9 | Sheath Length 19.13 cm | 5 | Withdrawn |
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
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Oscor Inc. | 510(k) number | 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 | |
| Oscor Inc. | 510(k) number | 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 | |
| Oscor Inc. | 510(k) number | 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 | |
| AngioDynamics, Inc. | 510(k) number | 2021-02-22 | Class II | Under Investigation by firm | AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified be | 337 units, (14 boxes of 5, 267 units each kit) | 2022-07-19 |
Recalls
32 of these are Class II. 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 |
|---|---|---|---|---|---|
| 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 | |
| 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.