Perclose Vascular Suture Delivery Device
FDA 510(k) K001703 · Abbott Vascular, Inc.
510(k) numberK001703
Submission
- Device name
- Perclose Vascular Suture Delivery Device
- Applicant
- Abbott Vascular, Inc.
Redwood, CA, US - Received
- June 5, 2000
- Decision date
- October 3, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAW – Suture, Nonabsorbable, Synthetic, Polypropylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5010
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K230746 | Non absorbable Surgical Polypropylene SutureGAW · Traditional | Shandong Haidike Medical Products Co., Ltd. | 09/14/2023SE |
| K221280 | VessealGAW · Traditional | Lydus Medical , Ltd. | 12/09/2022SE |
| K211178 | DURAMESH Mesh SutureGAW · Traditional | Msi | 09/02/2022SE |
| K192953 | APTOS Threads Polypropylene Surgical SuturesGAW · Traditional | Aptos, LLC | 08/27/2020SE |
| K193530 | Deklene MAXXGAW · Special | Teleflex Medical | 03/19/2020SE |
| K191299 | Silhouette Featherlift / Silhouette LiftGAW · Special | Silhouette Lift, Inc. | 06/14/2019SE |
| K173747 | RexleneGAW · Traditional | Sm Eng Co., Ltd. | 12/21/2018SE |
| K180321 | Aesculap Optilene Nonabsorbable SutureGAW · Special | Aesculap, Inc. | 03/07/2018SE |
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Questions and answers
When was Perclose Vascular Suture Delivery Device cleared by the FDA?
Perclose Vascular Suture Delivery Device (K001703) received a 510(k) decision of Substantially Equivalent on October 3, 2000, 120 days after the submission was received.
What is the product code of K001703?
The FDA product code is GAW – Suture, Nonabsorbable, Synthetic, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 878.5010.