Input™ TS
Intrdcr 011101A 5PK 11F 11CM ENH Inst TS
13manufacturers in China registered for this device type
19catalogue numbers in this listing
3510(k) clearances naming this product code
2recalls 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 | Medtronic, Inc., United States |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K961135 |
| Record published | 2017-02-03 |
| Record revised | 2024-03-20 (version 5) |
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 |
| Packaging | Pack of 5 |
| Sizes | Outer diameter 0.97 mm; length 7 to 23 cm; catheter gauge 5 to 11 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 011101A | Outer Diameter 0.97 mm | In distribution |
| 051101A | Catheter Gauge 5.0 Fr | In distribution |
| 080037A | Outer Diameter 0.97 mm | In distribution |
| 090037A | Outer Diameter 0.97 mm | In distribution |
| 091102A | Outer Diameter 0.97 mm | In distribution |
| 081102A | Outer Diameter 0.97 mm | In distribution |
| 051102A | Catheter Gauge 5.0 Fr | In distribution |
| 091101A | Catheter Gauge 9.0 Fr | In distribution |
| 040028A | Catheter Gauge 5.0 Fr | In distribution |
| 070037A | Catheter Gauge 7.0 Fr | In distribution |
| 071102A | Outer Diameter 0.97 mm | In distribution |
| 010101A | Outer Diameter 0.97 mm | In distribution |
| 081101A | Length 11.0 cm | In distribution |
| 061101A | Outer Diameter 0.97 mm | In distribution |
| 061102A | Length 11.0 cm | In distribution |
| 071101A | Catheter Gauge 7.0 Fr | In distribution |
| 060037A | Catheter Gauge 6.0 Fr | In distribution |
| 040035A | Outer Diameter 0.97 mm | In distribution |
| 040031A | Length 7.0 cm | 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 |
|---|---|
| K152054 | 2015-08-07 |
| K132617 | 2014-04-30 |
| K132030 | 2013-09-27 |
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 |
|---|---|---|---|---|---|---|---|
| Medtronic Vascular | 510(k) number | 2008-10-07 | Not classified | Nonconforming Material/Component | Failure to insert the guidewire through the 18 gauge introducer needle | 1,830 | 2011-06-07 |
| Medtronic Vascular | 510(k) number | 2008-10-07 | Not classified | Nonconforming Material/Component | Failure to insert the guidewire through the 18 gauge introducer needle | 2,585 units | 2011-06-07 |
| Medtronic Vascular | 510(k) number | 2008-10-07 | Not classified | Nonconforming Material/Component | Failure to insert the guidewire through the 18 gauge introducer needle | 1,805 units | 2011-06-07 |
| Medtronic Vascular | 510(k) number | 2008-10-07 | Not classified | Nonconforming Material/Component | Failure to insert the guidewire through the 18 gauge introducer needle | 335 units | 2011-06-07 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2015-02-23 | Class I | Nonconforming Material/Component | Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies. | 151 (4 US, 147 OUS) | 2015-10-07 |
| 2013-07-08 | Class II | Packaging change control | Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sheath, model 008551, in which packages labeled as Mullins 7F (French) may actually contain an 8F(French) dilator. Medtronic is req | 269 | 2014-03-06 |
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.