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FDA 510(k)

SYNCARE TEMPORARY CARDIAC PACING WIRE

K-Number: K861409 · 1986-05-05

ApplicantGyneco, Inc.
Decision Date1986-05-05
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SYNCARE TEMPORARY CARDIAC PACING WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Gyneco, Inc.. It received FDA 510(k) clearance on 1986-05-05 under 510(k) number K861409. 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 SYNCARE TEMPORARY CARDIAC PACING WIRE?

SYNCARE TEMPORARY CARDIAC PACING WIRE is a medical device that received FDA 510(k) clearance on 1986-05-05. The listed applicant is Gyneco, Inc.. The 510(k) number is K861409.

When did SYNCARE TEMPORARY CARDIAC PACING WIRE receive FDA 510(k) clearance?

SYNCARE TEMPORARY CARDIAC PACING WIRE received FDA 510(k) clearance on 1986-05-05, under 510(k) number K861409.

Who is the listed applicant for SYNCARE TEMPORARY CARDIAC PACING WIRE?

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

What is the FDA product code for SYNCARE TEMPORARY CARDIAC PACING WIRE?

The FDA product code for SYNCARE TEMPORARY CARDIAC PACING WIRE is LDF.

Related Clinical Trials

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Other records listing Gyneco, 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.

K853216MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4K852357GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIPK843941ENDOCYTEK841275FINE NEEDLE ASPIRATION DEVICE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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