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FDA 510(k)

MANAN MALECOT BASKET DRAINAGE CATHETER

K-Number: K981258 · 1998-04-22

ApplicantMedical Device Technologies, Inc.
Decision Date1998-04-22
Product CodeFEW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MANAN MALECOT BASKET DRAINAGE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Technologies, Inc.. It received FDA 510(k) clearance on 1998-04-22 under 510(k) number K981258. The device is classified under product code FEW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANAN MALECOT BASKET DRAINAGE CATHETER?

MANAN MALECOT BASKET DRAINAGE CATHETER is a medical device that received FDA 510(k) clearance on 1998-04-22. The listed applicant is Medical Device Technologies, Inc.. The 510(k) number is K981258.

When did MANAN MALECOT BASKET DRAINAGE CATHETER receive FDA 510(k) clearance?

MANAN MALECOT BASKET DRAINAGE CATHETER received FDA 510(k) clearance on 1998-04-22, under 510(k) number K981258.

Who is the listed applicant for MANAN MALECOT BASKET DRAINAGE CATHETER?

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

What is the FDA product code for MANAN MALECOT BASKET DRAINAGE CATHETER?

The FDA product code for MANAN MALECOT BASKET DRAINAGE CATHETER is FEW.

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Related Devices (Code: FEW)

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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