Crosser iQ CTO Recanalization System
FDA 510(k) clearance K203363 · decided 2021-08-12
Clearance details
- K-number
- K203363
- Device name
- Crosser iQ CTO Recanalization System
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-11-16
- Decision date
- 2021-08-12
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- PDU
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tempe, AZ, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch C.R. Bard
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Santreva™-ATK Endovascular Revasculariztion Catheter (K252315) | AngioSafe, Inc. | 2025-09-22 |
| PowerWire® 14 Radiofrequency Guidewire Kit (K251158) | Baylis Medical Technologies, Inc. | 2025-09-11 |
| LimFlow ARC (K251376) | LimFlow, Inc. | 2025-05-31 |
| PowerWire Radiofrequency Guidewire Kit (K232562) | Baylis Medical Technologies, Inc. | 2024-02-28 |
| SoundBite® Crossing System XS Peripheral (K230159) | Soundbite Medical Solutions, Inc. | 2023-08-28 |
| Tigereye ST CTO-Crossing Catheter (K230594) | Avinger, Inc. | 2023-04-25 |
| Tunnel Crossing Catheter (K221163) | Tractus Vascular, LLC | 2023-01-19 |
| LimFlow ARC (K221541) | LimFlow, Inc. | 2022-08-31 |
| DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) (K220544) | Ra Medical Systems,Inc | 2022-06-29 |
| GoBack Crossing Catheter (K211802) | Upstream Peripheral Technologies, Ltd. | 2022-03-01 |
| Tigereye CTO-Crossing Catheter (K212468) | Avinger, Inc. | 2022-01-06 |
| DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) (K210664) | Ra Medical Systems,Inc | 2021-07-27 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Recanalization System, REF: BDRECANSYSTEM recall (Z-0676-2024) | Bard Peripheral Vascular Inc | 2024-01-05 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Covera Vascular Covered Stent (P170042/S014) | C.R. Bard, Inc. | 2025-12-16 |
| Covera Vascular Covered Stents (P170042/S013) | C.R. Bard, Inc. | 2025-06-26 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S033) | C.R. Bard, Inc. | 2025-03-13 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032) | C.R. Bard, Inc. | 2025-02-18 |
| Avitene Bulk Flour Cleanroom Expansion (P800002/S031) | C.R. Bard, Inc. | 2024-01-18 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S030) | C.R. Bard, Inc. | 2023-10-04 |
| Covera Vascular Covered Stent (P170042/S012) | C.R. Bard, Inc. | 2023-02-02 |
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027) | C.R. Bard, Inc. | 2022-04-01 |