FDA 510(k)

HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE

K-Number: K852797 · 1985-09-16

Decision Date1985-09-16

Product CodeLDF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Mansfield Scientific, Inc.. It received FDA 510(k) clearance on 1985-09-16 under 510(k) number K852797. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE?

HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE is a medical device that received FDA 510(k) clearance on 1985-09-16. The listed applicant is Mansfield Scientific, Inc.. The 510(k) number is K852797.

When did HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE receive FDA 510(k) clearance?

HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE received FDA 510(k) clearance on 1985-09-16, under 510(k) number K852797.

Who is the listed applicant for HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE?

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

What is the FDA product code for HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE?

The FDA product code for HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE is LDF.

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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.