PERCLOSE VASCULAR SUTURE DELIVERY DEVICE
FDA 510(k) clearance K001703 · decided 2000-10-03
Clearance details
- K-number
- K001703
- Device name
- PERCLOSE VASCULAR SUTURE DELIVERY DEVICE
- Applicant
- Abbott Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-06-05
- Decision date
- 2000-10-03
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- GAW
- Device class
- 2
- Regulation number
- 878.5010
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Redwood, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
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| Non absorbable Surgical Polypropylene Suture (K230746) | Shandong Haidike Medical Products Co., Ltd. | 2023-09-14 |
| Vesseal (K221280) | Lydus Medical , Ltd. | 2022-12-09 |
| DURAMESH Mesh Suture (K211178) | Msi | 2022-09-02 |
| APTOS Threads – Polypropylene Surgical Sutures (K192953) | Aptos, LLC | 2020-08-27 |
| Deklene MAXX (K193530) | Teleflex Medical | 2020-03-19 |
| Silhouette Featherlift / Silhouette Lift (K191299) | Silhouette Lift, Inc. | 2019-06-14 |
| REXLENE (K173747) | Sm Eng Co., Ltd. | 2018-12-21 |
| Aesculap Optilene Nonabsorbable Suture (K180321) | Aesculap, Inc. | 2018-03-07 |
| Gazelle Polypropylene Suture and Delivery Device (K173644) | Dura Tap, LLC | 2018-02-15 |
| Assut Filbloc Permanent Sutures (K171039) | Assut Europe S.P.A. | 2017-08-29 |
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 |