Prowler
PROWLER 10 Infusion Catheter with 2 Markers Infusion Catheter 2.3F (0.75 mm) 1.7F (0.55 mm) .015 Inch (0.4 mm) 3 cm 50 cm 150 cm MAX Contents: 1 Infusion Catheter and 1 Shape Mandrel.…
PROWLER 10 Infusion Catheter with 2 Markers Infusion Catheter 2.3F (0.75 mm) 1.7F (0.55 mm).015 Inch (0.4 mm) 3 cm 50 cm 150 cm MAX Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum Guiding Catheter I.D. / Dia..035 Inch (0.9 mm)
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) | K003925 |
| Record published | 2016-06-30 |
| Record revised | 2020-03-04 (version 6) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 606-051JX | In distribution | |
| 606-2310J | In distribution | |
| 606-051X | In distribution | |
| 606-2510X | In distribution | |
| 606-151JX | In distribution | |
| 606-051MX | In distribution | |
| 606-2510FX | In distribution | |
| 606-2910 | In distribution | |
| 606-151 | In distribution | |
| 606-2511X | In distribution | |
| MC1755J2U | In distribution | |
| 606-051 | In distribution | |
| 606-2310M | In distribution | |
| 606-2510JX | In distribution | |
| 606-151FX | In distribution | |
| 606-2511 | In distribution | |
| 606-2310F | In distribution | |
| 606-051FX | In distribution | |
| 606-2510 | In distribution | |
| 606-2511FX | In distribution | |
| 606-2510MX | In distribution | |
| 606-151X | In distribution | |
| MC2155S2U | In distribution | |
| 606-2310 | In distribution | |
| 606-171 | In distribution | |
| 606-151MX | In distribution | |
| 606-131 | 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 |
| 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 |
| Deltran | Utah Medical Products, Inc. | 19 |
Showing 12 of 149. All products under Catheter, Continuous Flush
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.