Direxion™ Fathom™-16 System
10 catalogue numbers from M001195630, listed by Boston Scientific Corporation, United States, under Catheter, Continuous Flush. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
10catalogue numbers in this listing
11510(k) clearances naming this product code
7recalls on this 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 | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | KRA |
| Device type | Catheter, Continuous Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1210 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2019-07-25 |
| Record revised | 2019-03-21 (version 3) |
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 |
| Sizes | Catheter inner diameter 0.021 in; catheter working length 155 cm; guidewire length 200 cm |
| Distribution end date | 2021-09-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M001195630 | 0.021 in Diameter | In distribution |
| M001195650 | 180 cm Length | In distribution |
| M001195610 | 0.021 in Diameter | In distribution |
| M001195670 | 180 cm Length | In distribution |
| M001195660 | 0.021 in Diameter | In distribution |
| M001195620 | 180 cm Length | In distribution |
| M001195640 | 0.021 in Diameter | In distribution |
| M001195600 | 0.021 in Diameter | In distribution |
| M001195990 | Catheter Inner Diameter 0.021 in | Withdrawn |
| M001195980 | Catheter Inner Diameter 0.021 in | Withdrawn |
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 |
|---|---|
| K260771 | 2026-05-15 |
| K201792 | 2020-07-28 |
| K163701 | 2017-05-16 |
| K142259 | 2014-09-10 |
| K140329 | 2014-05-15 |
| K132947 | 2013-10-18 |
| K100892 | 2010-04-12 |
| K000177 | 2000-04-07 |
| K973645 | 1997-11-19 |
| K963988 | 1996-12-12 |
| K945666 | 1995-06-21 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-11-03 | Class II | Device Design | This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures. All EKOS CU 4.0 consoles containing the old RF | 90 (OUS) | |
| 2009-08-26 | Not classified | Packaging | Boston Scientific has determined that the sterile barrier in the packaging of the affected product may be compromised. It has been reported that the pouch seal (top seal) may be breached. | 9,088 | 2012-08-24 |
| 2009-08-26 | Not classified | Packaging | Boston Scientific has determined that the sterile barrier in the packaging of the affected product may be compromised. It has been reported that the pouch seal (top seal) may be breached. | 28,947 (11,050 US; 17,897 OUS) | 2012-08-24 |
| 2009-08-26 | Not classified | Packaging | Boston Scientific has determined that the sterile barrier in the packaging of the affected product may be compromised. It has been reported that the pouch seal (top seal) may be breached. | 80,885 (51,491 US; 29,394 OUS) | 2012-08-24 |
| 2009-08-24 | Not classified | Packaging process control | Sterility Loss– The sterile barrier pouch seal (top seal) may be breached by the product, resulting in loss of sterility which may result in transmission of disease or infection. | 2011-02-03 | |
| 2009-08-24 | Not classified | Packaging process control | Sterility Loss– The sterile barrier pouch seal (top seal) may be breached by the product, resulting in loss of sterility which may result in transmission of disease or infection. | 2011-02-03 | |
| 2007-09-10 | Not classified | Packaging process control | Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire. | 153 | 2007-12-20 |
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.