FDA 510(k)

HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER

K-Number: K951098 · 1995-06-02

Decision Date1995-06-02

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER is the device name listed in this FDA 510(k) record. The listed applicant is Hdc Corp.. It received FDA 510(k) clearance on 1995-06-02 under 510(k) number K951098. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER?

HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER is a medical device that received FDA 510(k) clearance on 1995-06-02. The listed applicant is Hdc Corp.. The 510(k) number is K951098.

When did HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER receive FDA 510(k) clearance?

HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER received FDA 510(k) clearance on 1995-06-02, under 510(k) number K951098.

Who is the listed applicant for HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER?

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

What is the FDA product code for HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER?

The FDA product code for HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER is LJS.

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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.