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FDA 510(k)

VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M

K-Number: K130873 · 2013-09-13

ApplicantVital Access
Decision Date2013-09-13
Product CodePFH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M is the device name listed in this FDA 510(k) record. The listed applicant is Vital Access. It received FDA 510(k) clearance on 2013-09-13 under 510(k) number K130873. The device is classified under product code PFH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M?

VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M is a medical device that received FDA 510(k) clearance on 2013-09-13. The listed applicant is Vital Access. The 510(k) number is K130873.

When did VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M receive FDA 510(k) clearance?

VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M received FDA 510(k) clearance on 2013-09-13, under 510(k) number K130873.

Who is the listed applicant for VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M?

The FDA 510(k) record lists Vital Access as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M?

The FDA product code for VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M is PFH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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