FDA 510(k)

TRUEFILL PVA PARTICLES

K-Number: K951314 · 1995-08-08

Decision Date1995-08-08

Product CodeHCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TRUEFILL PVA PARTICLES is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Neurovascular, Inc.. It received FDA 510(k) clearance on 1995-08-08 under 510(k) number K951314. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUEFILL PVA PARTICLES?

TRUEFILL PVA PARTICLES is a medical device that received FDA 510(k) clearance on 1995-08-08. The listed applicant is Cordis Neurovascular, Inc.. The 510(k) number is K951314.

When did TRUEFILL PVA PARTICLES receive FDA 510(k) clearance?

TRUEFILL PVA PARTICLES received FDA 510(k) clearance on 1995-08-08, under 510(k) number K951314.

Who is the listed applicant for TRUEFILL PVA PARTICLES?

The FDA 510(k) record lists Cordis Neurovascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRUEFILL PVA PARTICLES?

The FDA product code for TRUEFILL PVA PARTICLES is HCG.

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Official Source

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