Cri Vessel Occlusin System/Cri Occlusion Coil
FDA 510(k) K914523 · Catheter Research C/O Burditt, Bowles & Radzius
510(k) numberK914523
Submission
- Device name
- Cri Vessel Occlusin System/Cri Occlusion Coil
- Applicant
- Catheter Research C/O Burditt, Bowles & Radzius
Indianapolis, IN, US - Received
- October 10, 1991
- Decision date
- January 10, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DSS – Clip, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3250
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DSS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K983744 | Mcas (Modular Clip Applier System)DSS · Traditional | Applied Medical Resources | 01/21/1999SE |
| K961333 | Heartport Multifire Clip ApplierDSS · Traditional | Heartport, Inc. | 11/15/1996SE |
| K920104 | Identi Loops Degania SiliconeDSS · Traditional | Puritas Health Care, Inc. | 04/20/1992SE |
| K920676 | Rmi SofclampDSS · Traditional | Research Medical, Inc. | 04/15/1992SE |
| K901303 | Horizon Surgical Ligating and Marking ClipDSS · Traditional | Horizon Surgical, Inc. | 06/05/1990SE |
| K883909 | Surgical Spring ClipsDSS · Traditional | Applied Vascular Devices, Inc. | 12/27/1988SE |
| K771021 | Auto-ClipDSS · Traditional | Axiom Medical, Inc. | 06/14/1977SE |
More from Axiom Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K924227 | Cri Cynosar CatheterDRA · Traditional | 06/29/1993SE |
| K924125 | Cri Electronic Control SystemDXX · Traditional | 05/26/1993SE |
| K904785 | Cri Cynosar CatheterDRA · Traditional | 03/06/1991SE |
| K904787 | Cri Steerable Catheter Control SystemDXX · Traditional | 12/17/1990SE |
| K900320 | Cri Cynosar CatheterDRA · Traditional | 09/14/1990SE |
| K884337 | Micro-Guide SystemDRA · Traditional | 01/05/1989SE |
| K870700 | Micro-GuideDQO · Traditional | 12/03/1987SE |
Questions and answers
When was Cri Vessel Occlusin System/Cri Occlusion Coil cleared by the FDA?
Cri Vessel Occlusin System/Cri Occlusion Coil (K914523) received a 510(k) decision of Substantially Equivalent on January 10, 1992, 92 days after the submission was received.
What is the product code of K914523?
The FDA product code is DSS – Clip, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.3250.