Heartstring III Proximal Seal System
FDA 510(k) K130382 · Boston Scientific Corporation
510(k) numberK130382
Submission
- Device name
- Heartstring III Proximal Seal System
- Applicant
- Boston Scientific Corporation
Wayne, NJ, US - Received
- February 14, 2013
- Decision date
- June 5, 2013
- 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 Heartstring III Proximal Seal System cleared by the FDA?
Heartstring III Proximal Seal System (K130382) received a 510(k) decision of Substantially Equivalent on June 5, 2013, 111 days after the submission was received.
What is the product code of K130382?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.