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FDA 510(k)

MICRO-GUIDE SYSTEM

K-Number: K884337 · 1989-01-05

ApplicantCatheter Research C/O Burditt, Bowles & Radzius
Decision Date1989-01-05
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MICRO-GUIDE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Catheter Research C/O Burditt, Bowles & Radzius. It received FDA 510(k) clearance on 1989-01-05 under 510(k) number K884337. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-GUIDE SYSTEM?

MICRO-GUIDE SYSTEM is a medical device that received FDA 510(k) clearance on 1989-01-05. The listed applicant is Catheter Research C/O Burditt, Bowles & Radzius. The 510(k) number is K884337.

When did MICRO-GUIDE SYSTEM receive FDA 510(k) clearance?

MICRO-GUIDE SYSTEM received FDA 510(k) clearance on 1989-01-05, under 510(k) number K884337.

Who is the listed applicant for MICRO-GUIDE SYSTEM?

The FDA 510(k) record lists Catheter Research C/O Burditt, Bowles & Radzius as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICRO-GUIDE SYSTEM?

The FDA product code for MICRO-GUIDE SYSTEM is DRA.

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Other records listing Catheter Research C/O Burditt, Bowles & Radzius as applicant

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Related Devices (Code: DRA)

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.

K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific CorporationK250529Globe Introducer (601-01001)Kardium, Inc.K233248FARADRIVE™ Steerable SheathBoston Scientific CorporationK232321FlexCath Contour™ Steerable SheathMedtronic, Inc.K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure SensorBoston Scientific CorporationK221397MitraClip G4 Steerable Guide CatheterABBOTT MEDICAL

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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