CHITO-SEAL
FDA 510(k) clearance K021062 · decided 2002-08-23
Clearance details
- K-number
- K021062
- Device name
- CHITO-SEAL
- Applicant
- Abbott Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-02
- Decision date
- 2002-08-23
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- QSY
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Redwood, CA, 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 |
|---|---|---|
| Perclose ProGlide® Suture-Mediated Closure System; Prostar® XL Percutaneous Vascular Surgical System (P960043/S127) | Abbott Vascular, Inc. | 2025-12-09 |
| XACT® Carotid Stent System (P040038/S048) | Abbott Vascular, Inc. | 2025-12-09 |
| Absolute Pro Vascular (P110028/S025) | Abbott Vascular, Inc. | 2025-10-22 |
| XACT Carotid Stent System (XACT CSS) and XACT Transcarotid Stent System (XACT TSS) (P040038/S050) | Abbott Vascular, Inc. | 2025-10-17 |
| XACT Carotid Stent System (P040038/S049) | Abbott Vascular, Inc. | 2025-08-25 |
| Absolute Pro Vascular Self-Expanding Stent System (P110028/S024) | Abbott Vascular, Inc. | 2025-07-22 |
| XACT Carotid Stent System (P040038/S047) | Abbott Vascular, Inc. | 2025-03-09 |
| Perclose ProGlide Suture-Mediated Closure System, Prostar XL Percutaneous Vascular Surgical System (P960043/S125) | Abbott Vascular, Inc. | 2025-03-09 |