510(k) K983744
- Device
- MCAS (MODULAR CLIP APPLIER SYSTEM)
- Applicant
- APPLIED MEDICAL RESOURCES
- 510(k) number
- K983744
- Product code
- DSS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-01-21
- Date received
- 1998-10-23
- Regulation
- 870.3250
- Classification name
- Clip, Vascular
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HOWARD V ROWE
- Address
- 26051 Merit Cir. Bldg. 104 Launa Hills CA US 92653 92653
FDA Registration Numbers#
- 1054241
- 1422634
- 3009051888
- 1417592
- 1043214
- 1055236
- 8040233
- 3020965506
- 3009763019
- 3010041511
- 2027111
- 3008236846
- 9610612
- 2916714
- 9710524
- 3011137372
- 3003898360
Source Documents#
Other 510(k) Records For Product Code DSS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K961333 | HEARTPORT MULTIFIRE CLIP APPLIER | Heartport, Inc. | 1996-11-15 |
| K920104 | IDENTI LOOPS DEGANIA SILICONE | Puritas Health Care, Inc. | 1992-04-20 |
| K920676 | RMI SOFCLAMP | Research Medical, Inc. | 1992-04-15 |
| K914523 | CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL | Catheter Research C/O Burditt, Bowles & Radzius | 1992-01-10 |
| K901303 | HORIZON SURGICAL LIGATING AND MARKING CLIP | Horizon Surgical, Inc. | 1990-06-05 |
| K883909 | SURGICAL SPRING CLIPS | Applied Vascular Devices, Inc. | 1988-12-27 |
| K771021 | AUTO-CLIP | Axiom Medical, Inc. | 1977-06-14 |
Legacy Summary#
summary
FDA Review#
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