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FDA 510(k)

TEMPORARY ATRIAL ELECTRODE KIT

K-Number: K760403 · 1976-08-23

ApplicantUsci, Div. C.R. Bard, Inc.
Decision Date1976-08-23
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TEMPORARY ATRIAL ELECTRODE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Usci, Div. C.R. Bard, Inc.. It received FDA 510(k) clearance on 1976-08-23 under 510(k) number K760403. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPORARY ATRIAL ELECTRODE KIT?

TEMPORARY ATRIAL ELECTRODE KIT is a medical device that received FDA 510(k) clearance on 1976-08-23. The listed applicant is Usci, Div. C.R. Bard, Inc.. The 510(k) number is K760403.

When did TEMPORARY ATRIAL ELECTRODE KIT receive FDA 510(k) clearance?

TEMPORARY ATRIAL ELECTRODE KIT received FDA 510(k) clearance on 1976-08-23, under 510(k) number K760403.

Who is the listed applicant for TEMPORARY ATRIAL ELECTRODE KIT?

The FDA 510(k) record lists Usci, Div. C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEMPORARY ATRIAL ELECTRODE KIT?

The FDA product code for TEMPORARY ATRIAL ELECTRODE KIT is DRE.

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Other records listing Usci, Div. C.R. Bard, 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.

K940092USCI INPUT INTRODUCER SETK884209USCI DORROS INFUSION/PROBING CATHETERK771823CATHETER, CARDIOVASCULARK771982888 ARTERIAL/VENOUS CATHETER INTRODUCERK772021TRC STAINLESS STEEL SAFETY SPRING GUIDESK770835PATCH FABRIC

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Related Devices (Code: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

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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