SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T
FDA 510(k) clearance K994191 · decided 2000-02-08
Clearance details
- K-number
- K994191
- Device name
- SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T
- Applicant
- Nmt Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-12-13
- Decision date
- 2000-02-08
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- HCI
- Device class
- 2
- Regulation number
- 882.4175
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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| MEDICON YASARGIL CLIP APPLYING FORCEPS (K010910) | Medicon EG | 2001-08-01 |
| AESCULAP AXIAL CLIP APPLIER (K984109) | Aesculap, Inc. | 1999-02-12 |
| SUNDT SLIM-LINE ANEURYSM CLIP APPLIER (K982379) | Johnson & Johnson Professionals, Inc. | 1998-12-18 |
| PERNECZKY CLIP APPLIER/REMOVER (K954658) | Von Zeppelin GmbH | 1996-10-08 |
| YASARGIL, CASPAR, VARIO CLIP APPLIERS (K940970) | Aesculap, Inc. | 1995-01-24 |
| SUNDT AVM MICRO CLIP (K902544) | Codman & Shurtleff, Inc. | 1990-09-20 |
| SANO CLIP APPLIERS & REMOVERS (K881912) | Downs Surgical , Ltd. | 1988-06-06 |
| NEW SIZES SUGITA CLIPS (K881911) | Downs Surgical , Ltd. | 1988-06-06 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| STARFLEX SEPTAL OCCLUSION SYSTEM (P000049/S016) | Nmt Medical, Inc. | 2009-03-05 |
| CARDIOSEAL SEPTAL OCCLUSION WITH QWIK LOAD (P000049/S019) | Nmt Medical, Inc. | 2008-01-17 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD (P000049/S015) | Nmt Medical, Inc. | 2004-09-13 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD (P000049/S014) | Nmt Medical, Inc. | 2004-05-21 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM (P000049/S013) | Nmt Medical, Inc. | 2004-05-14 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD (P000049/S012) | Nmt Medical, Inc. | 2004-05-10 |
| CARDIOSEAL SEPTAL OCCULUSION SYSTEM WITH QWIK LOAD (P000049/S011) | Nmt Medical, Inc. | 2004-03-24 |
| CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD (P000049/S009) | Nmt Medical, Inc. | 2003-07-03 |