FDA 510(k)

IPI ALGO-LINE CATHETER

K-Number: K911382 · 1991-07-18

ApplicantPudenz-Schulte Medical Research Corp.

Decision Date1991-07-18

Product CodeMAJ

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

IPI ALGO-LINE 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 1991-07-18 under 510(k) number K911382. The device is classified under product code MAJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPI ALGO-LINE CATHETER?

IPI ALGO-LINE CATHETER is a medical device that received FDA 510(k) clearance on 1991-07-18. The listed applicant is Pudenz-Schulte Medical Research Corp.. The 510(k) number is K911382.

When did IPI ALGO-LINE CATHETER receive FDA 510(k) clearance?

IPI ALGO-LINE CATHETER received FDA 510(k) clearance on 1991-07-18, under 510(k) number K911382.

Who is the listed applicant for IPI ALGO-LINE 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 IPI ALGO-LINE CATHETER?

The FDA product code for IPI ALGO-LINE CATHETER is MAJ.

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

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Related Devices (Code: MAJ)

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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.