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FDA 510(k)

ELECATH PACEWEDGE DUAL PRESS. BIPOLAR

K-Number: K832850 · 1983-10-19

ApplicantElectro-Catheter Corp.
Decision Date1983-10-19
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECATH PACEWEDGE DUAL PRESS. BIPOLAR is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Catheter Corp.. It received FDA 510(k) clearance on 1983-10-19 under 510(k) number K832850. 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 ELECATH PACEWEDGE DUAL PRESS. BIPOLAR?

ELECATH PACEWEDGE DUAL PRESS. BIPOLAR is a medical device that received FDA 510(k) clearance on 1983-10-19. The listed applicant is Electro-Catheter Corp.. The 510(k) number is K832850.

When did ELECATH PACEWEDGE DUAL PRESS. BIPOLAR receive FDA 510(k) clearance?

ELECATH PACEWEDGE DUAL PRESS. BIPOLAR received FDA 510(k) clearance on 1983-10-19, under 510(k) number K832850.

Who is the listed applicant for ELECATH PACEWEDGE DUAL PRESS. BIPOLAR?

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

What is the FDA product code for ELECATH PACEWEDGE DUAL PRESS. BIPOLAR?

The FDA product code for ELECATH PACEWEDGE DUAL PRESS. BIPOLAR is LDF.

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Other records listing Electro-Catheter Corp. 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.

K934785MULTIPACEK943257TIP DEFLECTOR (GENESIS)K933451OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK933450CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK934787SILICORE SEMI-FLOATERK874154ELECATH(R) TRANSESOPHAGEAL PACING CATHETER

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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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