Occlusion Clamp** Device
FDA 510(k) K964251 · United States Surgical, A Division of Tyco Healthc
510(k) numberK964251
Submission
- Device name
- Occlusion Clamp** Device
- Applicant
- United States Surgical, A Division of Tyco Healthc
Norwalk, CT, US - Received
- October 24, 1996
- Decision date
- May 23, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXC – Clamp, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
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| K042412 | Modified Spacemaker SystemGCJ · Special | 09/24/2004SE |
| K040594 | Herculon Soft Tissue Reattachment SystemHWC · Special | 03/31/2004SE |
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Questions and answers
When was Occlusion Clamp** Device cleared by the FDA?
Occlusion Clamp** Device (K964251) received a 510(k) decision of Substantially Equivalent on May 23, 1997, 211 days after the submission was received.
What is the product code of K964251?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.