UltraFlow
HPC Flow Directed Micro Catheter
5manufacturers in China registered for this device type
2catalogue numbers in this listing
17510(k) clearances naming this product code
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 | Micro Therapeutics, Inc., United States |
|---|---|
| FDA product code | KRA |
| Device type | Catheter, Continuous Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1210 |
| 510(k) | K093750 |
| Record published | 2015-10-09 |
| Record revised | 2021-12-22 (version 7) |
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: Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT; Storage environment temperature 50 to 90 °F |
| Sizes | Length 165 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 105-5066 | Length 165 cm | In distribution |
| 105-5065 | Length 165 cm | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113289 | 2012-08-01 |
| K090870 | 2009-05-01 |
| K051990 | 2006-01-04 |
| K042187 | 2004-09-02 |
| K034036 | 2004-02-13 |
| K031992 | 2003-08-07 |
| K030688 | 2003-03-28 |
| K024122 | 2003-03-07 |
| K024118 | 2003-02-03 |
| K010004 | 2001-02-13 |
| K002723 | 2000-09-28 |
| K001966 | 2000-07-20 |
| K993672 | 2000-01-04 |
| K974473 | 1998-06-17 |
| K980104 | 1998-04-10 |
| K964868 | 1997-05-20 |
| K954020 | 1996-01-02 |
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 |
|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2022-06-30 | Class II | Under Investigation by firm | Outer carton packaging of microcatheters were exposed to wet substance during transport. | 8 units |
| Covidien | 510(k) number | 2022-06-30 | Class II | Under Investigation by firm | Outer carton packaging of microcatheters were exposed to wet substance during transport. | 2 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.