Horizon Surgical Ligating and Marking Clip
FDA 510(k) K901303 · Horizon Surgical, Inc.
510(k) numberK901303
Submission
- Device name
- Horizon Surgical Ligating and Marking Clip
- Applicant
- Horizon Surgical, Inc.
Evergreen, CO, US - Received
- March 20, 1990
- Decision date
- June 5, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K914523 | Cri Vessel Occlusin System/Cri Occlusion CoilDSS · Traditional | Catheter Research C/O Burditt, Bowles & Radzius | 01/10/1992SE |
| K883909 | Surgical Spring ClipsDSS · Traditional | Applied Vascular Devices, Inc. | 12/27/1988SE |
| K771021 | Auto-ClipDSS · Traditional | Axiom Medical, Inc. | 06/14/1977SE |
Questions and answers
When was Horizon Surgical Ligating and Marking Clip cleared by the FDA?
Horizon Surgical Ligating and Marking Clip (K901303) received a 510(k) decision of Substantially Equivalent on June 5, 1990, 77 days after the submission was received.
What is the product code of K901303?
The FDA product code is DSS – Clip, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.3250.