Pronto
Pronto 035, 10F
1manufacturer
9catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | DXE |
| Device type | Catheter, Embolectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5150 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K103405 |
| Record published | 2018-11-08 |
| Record revised | 2024-06-24 (version 5) |
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 |
| Packaging | Box |
| Sizes | Catheter gauge 5 to 10 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN913533 | Catheter Gauge 8 Fr | In distribution |
| IPN913538 | Catheter Gauge 6 Fr | In distribution |
| IPN913532 | Catheter Gauge 7 Fr | In distribution |
| IPN913541 | Catheter Gauge 10 Fr | In distribution |
| IPN913530 | Catheter Gauge 5.5 Fr | In distribution |
| IPN927371 | In distribution | |
| IPN913540 | Catheter Gauge 5 Fr | In distribution |
| IPN913531 | Catheter Gauge 6 Fr | In distribution |
| IPN913539 | Catheter Gauge 6 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LeMaitre Embolectomy Catheter | Lemaitre Vascular, Inc. | 68 |
| LMI Arterial Embolectomy Catheter | Lucas Medical, Inc. | 63 |
| Indigo System | Penumbra Inc. | 60 |
| Fogarty | Edwards Lifesciences Technology Sarl | 44 |
| Arrow | Teleflex Medical LLC | 28 |
| Bard Latex-free Arterial Embolectomy Catheters | Applied Medical Resources Corp. | 22 |
| Biosensors Embolectomy Catheter | Bioptimal International Pte. Ltd. | 16 |
| Amplatz Goose Neck | Covidien LP | 15 |
| Amplatz Goose Neck™ | ev3, Inc. | 13 |
| LMI Thrombectomy Catheter | Lucas Medical, Inc. | 12 |
| LMI Occlusion Catheter | Lucas Medical, Inc. | 12 |
| Syntel Thrombectomy Catheter | Applied Medical Resources Corp. | 9 |
Showing 12 of 88. All products under Catheter, Embolectomy
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 | Closed |
|---|---|---|---|---|---|---|---|
| Vascular Solutions LLC | 510(k) number | 2011-07-11 | Not classified | Process control | Vascular Solutions , Inc recently discovered that there was a manufacturing defect with Pronto V4 extraction catheters (Models 4005, 4006, 4007, 4008). Use of this defective product could lead to a tip separation. This may cause injury and/ | 1086 | 2012-04-03 |
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.