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FDA 510(k)

REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES

K-Number: K070034 · 2007-08-17

ApplicantAscent Healthcare Solutions
Decision Date2007-08-17
Product CodeNQG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Ascent Healthcare Solutions. It received FDA 510(k) clearance on 2007-08-17 under 510(k) number K070034. The device is classified under product code NQG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES?

REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES is a medical device that received FDA 510(k) clearance on 2007-08-17. The listed applicant is Ascent Healthcare Solutions. The 510(k) number is K070034.

When did REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES receive FDA 510(k) clearance?

REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES received FDA 510(k) clearance on 2007-08-17, under 510(k) number K070034.

Who is the listed applicant for REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES?

The FDA 510(k) record lists Ascent Healthcare Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES?

The FDA product code for REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES is NQG.

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Other records listing Ascent Healthcare Solutions 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.

K111600REPROCESSED HAND ACTIVATE SEALER/DIVIDERK110189REPROCESSED ELECTROSURGICAL INSTRUMENTK100909REPROCESSED COMPRESSION SLEEVESK100254REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERK100537REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUEK100080REPROCESSED TROCARS, MODEL B5LT AND CB5LT

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Related Devices (Code: NQG)

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.

K070036REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICESAscent Healthcare SolutionsK063844REPROCESSED HEART STABILIZERS AND POSITIONERSSterilmed, 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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