Prowler Select
PROWLER SELECT PLUS TIP MARKERS 2 TIPSHAPE STRAIGHT Infusion Catheter 2.8F (0.95mm) 2.3F (0.75mm) .021 Inch (0.5mm) 15cm 150cm Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum…
PROWLER SELECT PLUS TIP MARKERS 2 TIPSHAPE STRAIGHT Infusion Catheter 2.8F (0.95mm) 2.3F (0.75mm).021 Inch (0.5mm) 15cm 150cm Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum Guiding Catheter I.D. / Dia..042 Inch (1.1mm)
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Vascupatent Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Medos International Sàrl, Switzerland |
|---|---|
| FDA product code | KRA |
| Device type | Catheter, Continuous Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1210 |
| 510(k) | K021591 |
| Record published | 2016-06-30 |
| Record revised | 2020-01-29 (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, expiry date |
| Storage | Special storage condition: STORE IN A COOL, DARK, DRY PLACE |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 606-S255X | In distribution | |
| 606-S155FX | In distribution | |
| 606-S252X | In distribution | |
| 606-S252 | In distribution | |
| 606-S255JX | In distribution | |
| 606-S252FX | In distribution | |
| 606-S155MX | In distribution | |
| 606-S272X | In distribution | |
| 606-S155X | In distribution | |
| 606-S255FX | In distribution | |
| 606-S255MX | In distribution | |
| 606-S155JX | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fountain® | Merit Medical Systems, Inc. | 154 |
| PulseSpray | AngioDynamics, Inc. | 149 |
| Merit Maestro® | Merit Medical Systems, Inc. | 143 |
| Phenom™ Catheter | Cathera, Inc. | 103 |
| UniFuse | AngioDynamics, Inc. | 84 |
| CXI | Cook Incorporated | 48 |
| Uni-Fuse+ | AngioDynamics, Inc. | 32 |
| Prowler | Medos International Sàrl | 27 |
| Truwave, Vamp | Edwards Lifesciences Technology Sarl | 26 |
| ICU Medical | ICU Medical, Inc | 21 |
| Cantata | Cook Incorporated | 20 |
| Truwave, Vamp Plus | Edwards Lifesciences Technology Sarl | 19 |
Showing 12 of 149. All products under Catheter, Continuous Flush
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 |
|---|---|---|---|---|---|---|---|
| Cordis Neurovascular, Inc. | 510(k) number | 2006-08-11 | Not classified | Other | Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER SELECT Infusion Catheters may have a pinh | 15 Lot numbers (46,452) | 2008-11-25 |
| Cordis Neurovascular, Inc. | 510(k) number | 2006-08-11 | Not classified | Other | Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER SELECT Infusion Catheters may have a pinh | 12 Lot numbers (14,161) | 2008-11-25 |
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.