Yasargil Permanent Aneurysm Clips
FDA 510(k) K003519 · Aesculap, Inc.
510(k) numberK003519
Submission
- Device name
- Yasargil Permanent Aneurysm Clips
- Applicant
- Aesculap, Inc.
Allentown, PA, US - Received
- November 15, 2000
- Decision date
- January 29, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HCH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K211183 | Sugita AVM MicroclipsHCH · Traditional | Mizuho America, Inc. | 03/02/2022SE |
| K180757 | D-Clip; D-Clip ApplierHCH · Traditional | Peter Lazic GmbH | 04/12/2019SE |
| K131500 | Yasargil Aneurysm Clips and Clip AppliersHCH · Traditional | Aesculap, Inc. | 01/24/2014SE |
| K091921 | Codman Aneurysm Clips, Codman Avm Micro Clip System, Codman Slim-Line Graft…HCH · Special | Codman & Shurtleff, Inc. | 09/08/2009SE |
| K081640 | Gimmi Aneurysm Clips and Applying ForcepsHCH · Abbreviated | Gimmi GmbH | 05/06/2009SE |
| K081489 | L-Aneurysm-Clip System & L-Aneurysm Clip Appliers, Yasargil Aneurysm Clips & Yasargil…HCH · Traditional | Peter Lazic GmbH | 09/25/2008SE |
| K060915 | Kirwan L-Aneurysm Clips and Applier, Kirwan Yasargil-Type Aneurysm Clips and AppliersHCH · Traditional | Kirwan Surgical Products, Inc. | 04/17/2007SE |
| K043041 | Aesculap T-Bar Aneurysm Clips (Titanium & Phynox)HCH · Special | Aesculap, Inc. | 12/09/2004SE |
| K032198 | Aesculap Yasargil Aneurysm Clip Phynox Booster ClipHCH · Special | Aesculap, Inc. | 08/20/2003SE |
| K031468 | Temporary Titanium Aneurysm ClipHCH · Traditional | Cardinalhealth | 06/20/2003SE |
More from Cardinalhealth
| 510(k) | Device | Decision |
|---|---|---|
| K242762 | Aesculap Aicon® Series Container SystemKCT · Traditional | 05/13/2025SE |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG · Traditional | 12/16/2024SE |
| K223596 | SQ.line KERRISONHAE · Traditional | 06/29/2023SE |
| K214041 | Aesculap AICON ContainerKCT · Traditional | 12/30/2022SE |
| K211572 | Aesculap Slim Clip ApplierHCI · Traditional | 12/13/2021SE |
| K203739 | ELAN 4 Electro Motor SystemHBE · Traditional | 08/24/2021SE |
| K202391 | Dir 800IZI · Traditional | 01/21/2021SE |
| K203461 | Aesculap Caiman 12 Seal and Cut Technology SystemGEI · Special | 12/18/2020SE |
| K202938 | Aesculap Caiman 5 Seal and Cut Technology SystemGEI · Special | 10/30/2020SE |
| K202124 | Aesculap PAS-Port Proximal Anastomosis SystemFZP · Special | 09/02/2020SE |
Questions and answers
When was Yasargil Permanent Aneurysm Clips cleared by the FDA?
Yasargil Permanent Aneurysm Clips (K003519) received a 510(k) decision of Substantially Equivalent on January 29, 2001, 75 days after the submission was received.
What is the product code of K003519?
The FDA product code is HCH – Clip, Aneurysm, a Class II (moderate risk) device regulated under 21 CFR 882.5200.