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FDA 510(k)

INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610

K-Number: K971775 · 1997-12-29

ApplicantCardiac Control Systems, Inc.
Decision Date1997-12-29
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Control Systems, Inc.. It received FDA 510(k) clearance on 1997-12-29 under 510(k) number K971775. 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 INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610?

INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 is a medical device that received FDA 510(k) clearance on 1997-12-29. The listed applicant is Cardiac Control Systems, Inc.. The 510(k) number is K971775.

When did INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 receive FDA 510(k) clearance?

INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 received FDA 510(k) clearance on 1997-12-29, under 510(k) number K971775.

Who is the listed applicant for INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610?

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

What is the FDA product code for INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610?

The FDA product code for INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 is LDF.

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Other records listing Cardiac Control Systems, Inc. as applicant

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Related Devices (Code: LDF)

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.

K252042Sync AV II Temporary Pacing CatheterSwift Sync, Inc.K242863Bioptimal Bipolar Pacing CatheterBioptimal International Pte. , Ltd.K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)C.R. Bard, Inc.K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,C.R. Bard, Inc.K241199Rotatable Connector (5944RL)Shenzhen Launch Electrical Co., Ltd.K242705Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)Medtronic, 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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