Introducer Kit for Impella®
Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13 cm and 25 cm
13manufacturers in China registered for this device type
11catalogue 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 | 2019-09-24 |
| Record revised | 2026-06-11 (version 7) |
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 | Length 6 to 30 cm |
| Distribution end date | 2019-07-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0052-3025 | Sheath Length 13 cm | In distribution |
| 0052-3014 | Length 13 cm | In distribution |
| 0052-3000 | Length 13 cm | In distribution |
| 0052-3001 | Length 30 cm | In distribution |
| 0052-3006 | Length 6 cm | In distribution |
| 0052-3015 | Length 25 cm | In distribution |
| 0052-3021 | Length 30 cm | In distribution |
| 0052-3025 | Sheath Length 13 cm | Withdrawn |
| 0052-3014 | Length 13 cm | Withdrawn |
| 0052-3021 | Length 30 cm | Withdrawn |
| 0052-3015 | Length 25 cm | 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
6 recalls name this product by its own identifiers, the UDI on its label or 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 | |
| Abiomed, Inc. | UDI-DI | 2023-11-07 | Class II | Process control | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into th | 717 single units; 1906 within sets | |
| Abiomed, Inc. | UDI-DI | 2023-11-07 | Class II | Process control | Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into th | 193 single units; 1034 units within kits | |
| 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.