CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP
FDA 510(k) clearance K091921 · decided 2009-09-08
Clearance details
- K-number
- K091921
- Device name
- CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP
- Applicant
- Codman & Shurtleff, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-06-30
- Decision date
- 2009-09-08
- Days to decision
- 70 days
- Clearance type
- Special
- Product code
- HCH
- Device class
- 2
- Regulation number
- 882.5200
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Raynham, MA, 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.
| Record | Firm | Date |
|---|---|---|
| Sugita AVM Microclips (K211183) | Mizuho America, Inc. | 2022-03-02 |
| D-Clip; D-Clip Applier (K180757) | Peter Lazic GmbH | 2019-04-12 |
| YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS (K131500) | Aesculap, Inc. | 2014-01-24 |
| GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS (K081640) | Gimmi GmbH | 2009-05-06 |
| L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS (K081489) | Peter Lazic GmbH | 2008-09-25 |
| KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS (K060915) | Kirwan Surgical Products, Inc. | 2007-04-17 |
| AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) (K043041) | Aesculap, Inc. | 2004-12-09 |
| AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP (K032198) | Aesculap, Inc. | 2003-08-20 |
| TEMPORARY TITANIUM ANEURYSM CLIP (K031468) | Cardinalhealth | 2003-06-20 |
| AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER (K024349) | Aesculap, Inc. | 2003-03-24 |
| ANEURYSM CLIPS (K013136) | Gistlstrasse | 2001-11-26 |
| MEDICON TITANIUM YASARGIL ANEURYSM CLIPS (K010908) | Medicon EG | 2001-08-01 |
Recalls involving this device
No recalls on record reference this clearance.