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FDA 510(k)

DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER

K-Number: K890794 · 1989-06-20

ApplicantDaig Corp.
Decision Date1989-06-20
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Daig Corp.. It received FDA 510(k) clearance on 1989-06-20 under 510(k) number K890794. 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 DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER?

DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER is a medical device that received FDA 510(k) clearance on 1989-06-20. The listed applicant is Daig Corp.. The 510(k) number is K890794.

When did DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER receive FDA 510(k) clearance?

DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER received FDA 510(k) clearance on 1989-06-20, under 510(k) number K890794.

Who is the listed applicant for DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER?

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

What is the FDA product code for DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER?

The FDA product code for DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER is LDF.

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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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