Vessix Guide Sheath 7F, 45 CM, RDC, Vessix Guide Sheath 7F, 45CM, Lima
FDA 510(k) K140641 · Boston Scientific Corporation
510(k) numberK140641
Submission
- Device name
- Vessix Guide Sheath 7F, 45 CM, RDC, Vessix Guide Sheath 7F, 45CM, Lima
- Applicant
- Boston Scientific Corporation
Maple Grove, MN, US - Received
- March 12, 2014
- Decision date
- July 3, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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Questions and answers
When was Vessix Guide Sheath 7F, 45 CM, RDC, Vessix Guide Sheath 7F, 45CM, Lima cleared by the FDA?
Vessix Guide Sheath 7F, 45 CM, RDC, Vessix Guide Sheath 7F, 45CM, Lima (K140641) received a 510(k) decision of Substantially Equivalent on July 3, 2014, 113 days after the submission was received.
What is the product code of K140641?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.