Fogarty-Hydragrip Surgical Clamps
FDA 510(k) K951413 · Baxter Healthcare Corp
510(k) numberK951413
Submission
- Device name
- Fogarty-Hydragrip Surgical Clamps
- Applicant
- Baxter Healthcare Corp
Mcgaw Park, IL, US - Received
- March 28, 1995
- Decision date
- August 18, 1995
- 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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Questions and answers
When was Fogarty-Hydragrip Surgical Clamps cleared by the FDA?
Fogarty-Hydragrip Surgical Clamps (K951413) received a 510(k) decision of Substantially Equivalent on August 18, 1995, 143 days after the submission was received.
What is the product code of K951413?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.