iCAST
iCAST COVERED STENT, 10MMX38MMX120CM
1manufacturer
34catalogue numbers in this listing
2510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
Record
| Listed by | Atrium Medical Corporation, United States |
|---|---|
| FDA product code | JCT |
| Device type | Prosthesis, Tracheal, Expandable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3720 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K050814 |
| Record published | 2015-09-24 |
| Record revised | 2024-02-29 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | expiry date, serial number |
| Distribution end date | 2024-02-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 85404 | Withdrawn | |
| 85454 | Withdrawn | |
| 85406 | Withdrawn | |
| 85413 | Withdrawn | |
| 85443 | Withdrawn | |
| 85419 | Withdrawn | |
| 85405 | Withdrawn | |
| 85442 | Withdrawn | |
| 85445 | Withdrawn | |
| 85417 | Withdrawn | |
| 85401 | Withdrawn | |
| 85452 | Withdrawn | |
| 85407 | Withdrawn | |
| 85410 | Withdrawn | |
| 85411 | Withdrawn | |
| 85400 | Withdrawn | |
| 85402 | Withdrawn | |
| 85409 | Withdrawn | |
| 85416 | Withdrawn | |
| 85415 | Withdrawn | |
| 85424 | Withdrawn | |
| 85451 | Withdrawn | |
| 85455 | Withdrawn | |
| 85440 | Withdrawn | |
| 85420 | Withdrawn | |
| 85412 | Withdrawn | |
| 85441 | Withdrawn | |
| 85403 | Withdrawn | |
| 85414 | Withdrawn | |
| 85450 | Withdrawn | |
| 85418 | Withdrawn | |
| 85444 | Withdrawn | |
| 85453 | Withdrawn | |
| 85408 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hanarostent® Trachea/Bronchium(CCC) | M.I.Tech Co Ltd | 84 |
| Bonastent® Tracheal/Bronchial | Sewoon Medical Co., Ltd. | 83 |
| Aero® | Merit Medical Systems, Inc. | 37 |
| Ultraflex™ Tracheobronchial | Boston Scientific Corporation | 36 |
| Wallstent™ RP Endoprosthesis | Boston Scientific Corporation | 32 |
| Tracheal Stent system (Y-shaped) | Micro-Tech (Nanjing) Co., Ltd. | 27 |
| Aero DV® | Merit Medical Systems, Inc. | 27 |
| Wallgraft® | Boston Scientific Corporation | 25 |
| AEROmini® | Merit Medical Systems, Inc. | 25 |
| Through the Scope Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 17 |
| Wallstent® Endoprosthesis | Boston Scientific Corporation | 16 |
| Gianturco-Rosch Cook-Z | Cook Incorporated | 5 |
Showing 12 of 14. All products under Prosthesis, Tracheal, Expandable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K050814 | 2005-05-06 |
| K041269 | 2004-09-14 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Atrium Medical Corporation | 510(k) number | 2022-03-03 | Class I | Device Design | Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing procedural delay and possible administration of additional ane | 68812 units | |
| Atrium Medical Corporation | 510(k) number | 2017-05-25 | Class II | Under Investigation by firm | Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the manifold (catheter hub) was printed as 7mm x 38 mm x 80 cm. The complaint was the result of inc | 246 (US: 183 units; Foreign: 63 units) | 2020-06-26 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2022-03-03 | Class I | Device Design | Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing procedural delay and possible administration of additional ane | 105,968 units |
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.