BOLTON PTA CATHETER
FDA 510(k) clearance K021996 · decided 2002-08-23
Clearance details
- K-number
- K021996
- Device name
- BOLTON PTA CATHETER
- Applicant
- Bolton Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-06-18
- Decision date
- 2002-08-23
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fair Lawn, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S033) | Bolton Medical, Inc. | 2025-10-10 |
| RelayPro Thoracic Stent-Graft System (P200045/S018) | Bolton Medical, Inc. | 2025-10-07 |
| RelayPro Thoracic Stent-Graft System (P200045/S020) | Bolton Medical, Inc. | 2025-09-10 |
| RelayPlus (P110038/S034) | Bolton Medical, Inc. | 2025-09-03 |
| RelayPro (P200045/S019) | Bolton Medical, Inc. | 2025-09-03 |
| TREO® Abdominal Stent-Graft System (P190015/S025) | Bolton Medical, Inc. | 2025-09-03 |
| RelayPro Thoracic Stent-Graft System (P200045/S016) | Bolton Medical, Inc. | 2025-07-22 |
| TREO Abdominal Stent-Graft System (P190015/S023) | Bolton Medical, Inc. | 2025-03-14 |