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FDA 510(k)

HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET

K-Number: K963073 · 1997-08-14

ApplicantHarmac Medical Products, Inc.
Decision Date1997-08-14
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET is the device name listed in this FDA 510(k) record. The listed applicant is Harmac Medical Products, Inc.. It received FDA 510(k) clearance on 1997-08-14 under 510(k) number K963073. 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 HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET?

HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET is a medical device that received FDA 510(k) clearance on 1997-08-14. The listed applicant is Harmac Medical Products, Inc.. The 510(k) number is K963073.

When did HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET receive FDA 510(k) clearance?

HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET received FDA 510(k) clearance on 1997-08-14, under 510(k) number K963073.

Who is the listed applicant for HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET?

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

What is the FDA product code for HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET?

The FDA product code for HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET is LDF.

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Other records listing Harmac Medical Products, 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.

K021916HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001K962829HARMAC BALLOON ANGIOGRAPHIC CATHETERK963335HARMAC BALLOON WEDGE PRESSURE CATHETERK962833HARMAC TEMPORARY PACING CATHETER WITH BALLOONK963336HARMAC THERMODILUTION CATHETERK963074HARMAC QUADPOLAR MAPPING PACING CATHETER

View all 8 devices →

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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