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FDA 510(k)

UNIVERSAL PACING ELECTRODE KIT

K-Number: K810643 · 1981-04-08

ApplicantStanco Medical, Inc.
Decision Date1981-04-08
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL PACING ELECTRODE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Stanco Medical, Inc.. It received FDA 510(k) clearance on 1981-04-08 under 510(k) number K810643. 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 UNIVERSAL PACING ELECTRODE KIT?

UNIVERSAL PACING ELECTRODE KIT is a medical device that received FDA 510(k) clearance on 1981-04-08. The listed applicant is Stanco Medical, Inc.. The 510(k) number is K810643.

When did UNIVERSAL PACING ELECTRODE KIT receive FDA 510(k) clearance?

UNIVERSAL PACING ELECTRODE KIT received FDA 510(k) clearance on 1981-04-08, under 510(k) number K810643.

Who is the listed applicant for UNIVERSAL PACING ELECTRODE KIT?

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

What is the FDA product code for UNIVERSAL PACING ELECTRODE KIT?

The FDA product code for UNIVERSAL PACING ELECTRODE KIT is LDF.

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Other records listing Stanco Medical, 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.

K810642ATRIAL-VENTRICULAR PACING ELECTRODE KITK802289PERICARDIOCENTESIS KITK802288SWAN GANZ CATHETER PLACEMENT KITK802287RIGHT ATRIAL LINE KITK802259TRANSVENOUS PACEMAKER ELECTRODE KITK802290REGIONAL INTRAVENOUS ANESTHESIA KIT

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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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