FDA 510(k)

SILICORE SEMI-FLOATER

K-Number: K934787 · 1995-02-24

Decision Date1995-02-24

Product CodeLDF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SILICORE SEMI-FLOATER 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 1995-02-24 under 510(k) number K934787. 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 SILICORE SEMI-FLOATER?

SILICORE SEMI-FLOATER is a medical device that received FDA 510(k) clearance on 1995-02-24. The listed applicant is Electro-Catheter Corp.. The 510(k) number is K934787.

When did SILICORE SEMI-FLOATER receive FDA 510(k) clearance?

SILICORE SEMI-FLOATER received FDA 510(k) clearance on 1995-02-24, under 510(k) number K934787.

Who is the listed applicant for SILICORE SEMI-FLOATER?

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 SILICORE SEMI-FLOATER?

The FDA product code for SILICORE SEMI-FLOATER is LDF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Electro-Catheter Corp. as applicant

K934785MULTIPACE K933451OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION K943257TIP DEFLECTOR (GENESIS)K933450CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION K874154ELECATH(R) TRANSESOPHAGEAL PACING CATHETER K854511ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET

View all 35 devices →

Related Devices (Code: LDF)

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.