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FDA 510(k)

SAFPACE SYSTEM

K-Number: K955829 · 1997-11-18

ApplicantB.Braun Medical, Inc.
Decision Date1997-11-18
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SAFPACE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 1997-11-18 under 510(k) number K955829. 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 SAFPACE SYSTEM?

SAFPACE SYSTEM is a medical device that received FDA 510(k) clearance on 1997-11-18. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K955829.

When did SAFPACE SYSTEM receive FDA 510(k) clearance?

SAFPACE SYSTEM received FDA 510(k) clearance on 1997-11-18, under 510(k) number K955829.

Who is the listed applicant for SAFPACE SYSTEM?

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

What is the FDA product code for SAFPACE SYSTEM?

The FDA product code for SAFPACE SYSTEM is LDF.

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Related Devices (Code: LDF)

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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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