FDA 510(k)

PS MEDICAL IPI VASCULAR ACCESS CATHETER

K-Number: K954409 · 1995-12-18

ApplicantPudenz-Schulte Medical Research Corp.

Decision Date1995-12-18

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PS MEDICAL IPI VASCULAR ACCESS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Pudenz-Schulte Medical Research Corp.. It received FDA 510(k) clearance on 1995-12-18 under 510(k) number K954409. 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 PS MEDICAL IPI VASCULAR ACCESS CATHETER?

PS MEDICAL IPI VASCULAR ACCESS CATHETER is a medical device that received FDA 510(k) clearance on 1995-12-18. The listed applicant is Pudenz-Schulte Medical Research Corp.. The 510(k) number is K954409.

When did PS MEDICAL IPI VASCULAR ACCESS CATHETER receive FDA 510(k) clearance?

PS MEDICAL IPI VASCULAR ACCESS CATHETER received FDA 510(k) clearance on 1995-12-18, under 510(k) number K954409.

Who is the listed applicant for PS MEDICAL IPI VASCULAR ACCESS CATHETER?

The FDA 510(k) record lists Pudenz-Schulte Medical Research Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PS MEDICAL IPI VASCULAR ACCESS CATHETER?

The FDA product code for PS MEDICAL IPI VASCULAR ACCESS CATHETER is LJS.

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Other records listing Pudenz-Schulte Medical Research Corp. as applicant

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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.