Mcas (Modular Clip Applier System)
FDA 510(k) K983744 · Applied Medical Resources
510(k) numberK983744
Submission
- Device name
- Mcas (Modular Clip Applier System)
- Applicant
- Applied Medical Resources
Launa Hills, CA, US - Received
- October 23, 1998
- Decision date
- January 21, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| 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 |
| K914523 | Cri Vessel Occlusin System/Cri Occlusion CoilDSS · Traditional | Catheter Research C/O Burditt, Bowles & Radzius | 01/10/1992SE |
| 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 |
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Questions and answers
When was Mcas (Modular Clip Applier System) cleared by the FDA?
Mcas (Modular Clip Applier System) (K983744) received a 510(k) decision of Substantially Equivalent on January 21, 1999, 90 days after the submission was received.
What is the product code of K983744?
The FDA product code is DSS – Clip, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.3250.