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FDA 510(k)

LIFELINC LEADWIRE

K-Number: K853303 · 1985-09-18

ApplicantTronomed, Inc.
Decision Date1985-09-18
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LIFELINC LEADWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Tronomed, Inc.. It received FDA 510(k) clearance on 1985-09-18 under 510(k) number K853303. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFELINC LEADWIRE?

LIFELINC LEADWIRE is a medical device that received FDA 510(k) clearance on 1985-09-18. The listed applicant is Tronomed, Inc.. The 510(k) number is K853303.

When did LIFELINC LEADWIRE receive FDA 510(k) clearance?

LIFELINC LEADWIRE received FDA 510(k) clearance on 1985-09-18, under 510(k) number K853303.

Who is the listed applicant for LIFELINC LEADWIRE?

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

What is the FDA product code for LIFELINC LEADWIRE?

The FDA product code for LIFELINC LEADWIRE is BZQ.

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Other records listing Tronomed, Inc. as applicant

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.

K952659TRONOMATE PATIENT CABLE & LEADWIRE SYSTEMK853452LIFE LINC PATIENT CABLEK841092HIGH PRESSURE FLEX. CONNECTING TUBINGK7921263&4 WAY PLASTIC STERILE STPCKS. PKG.K792124TANDEM ASSEMBLED 3&4 WAY STOPCOCKSK792128STERILE EXTENSION TUBES INDIV. PKG.

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Related Devices (Code: BZQ)

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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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