FDA 510(k)

PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID

K-Number: K850820 · 1985-04-10

ApplicantUniversal Medical Instrument Corp.

Decision Date1985-04-10

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID is the device name listed in this FDA 510(k) record. The listed applicant is Universal Medical Instrument Corp.. It received FDA 510(k) clearance on 1985-04-10 under 510(k) number K850820. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID?

PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID is a medical device that received FDA 510(k) clearance on 1985-04-10. The listed applicant is Universal Medical Instrument Corp.. The 510(k) number is K850820.

When did PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID receive FDA 510(k) clearance?

PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID received FDA 510(k) clearance on 1985-04-10, under 510(k) number K850820.

Who is the listed applicant for PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID?

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

What is the FDA product code for PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID?

The FDA product code for PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID is DYB.

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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.