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FDA 510(k)

COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER

K-Number: K983830 · 1999-04-16

ApplicantMallinckroot, Inc.
Decision Date1999-04-16
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckroot, Inc.. It received FDA 510(k) clearance on 1999-04-16 under 510(k) number K983830. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER?

COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER is a medical device that received FDA 510(k) clearance on 1999-04-16. The listed applicant is Mallinckroot, Inc.. The 510(k) number is K983830.

When did COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER receive FDA 510(k) clearance?

COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER received FDA 510(k) clearance on 1999-04-16, under 510(k) number K983830.

Who is the listed applicant for COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER?

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

What is the FDA product code for COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER?

The FDA product code for COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER is LIT.

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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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