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FDA 510(k)

ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER

K-Number: K960479 · 1996-10-17

ApplicantArrow Intl., Inc.
Decision Date1996-10-17
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 1996-10-17 under 510(k) number K960479. 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 ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER?

ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER is a medical device that received FDA 510(k) clearance on 1996-10-17. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K960479.

When did ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER receive FDA 510(k) clearance?

ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER received FDA 510(k) clearance on 1996-10-17, under 510(k) number K960479.

Who is the listed applicant for ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER?

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

What is the FDA product code for ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER?

The FDA product code for ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER is LDF.

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Other records listing Arrow Intl., Inc. as applicant

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K100635ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504K093050ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520K071491ARROW INTERNATIONAL, INC., SURGICAL DRAPESK071998ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENTK071111NON-ABSORBABLE SILK SUTUREK060309AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES

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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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