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FDA 510(k)

CRI CYNOSAR CATHETER

K-Number: K924227 · 1993-06-29

ApplicantCatheter Research C/O Burditt, Bowles & Radzius
Decision Date1993-06-29
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRI CYNOSAR CATHETER 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 1993-06-29 under 510(k) number K924227. 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 CRI CYNOSAR CATHETER?

CRI CYNOSAR CATHETER is a medical device that received FDA 510(k) clearance on 1993-06-29. The listed applicant is Catheter Research C/O Burditt, Bowles & Radzius. The 510(k) number is K924227.

When did CRI CYNOSAR CATHETER receive FDA 510(k) clearance?

CRI CYNOSAR CATHETER received FDA 510(k) clearance on 1993-06-29, under 510(k) number K924227.

Who is the listed applicant for CRI CYNOSAR CATHETER?

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 CRI CYNOSAR CATHETER?

The FDA product code for CRI CYNOSAR CATHETER is DRA.

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

K924125CRI ELECTRONIC CONTROL SYSTEMK914523CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COILK904785CRI CYNOSAR CATHETERK904787CRI STEERABLE CATHETER CONTROL SYSTEMK900320CRI CYNOSAR CATHETERK884337MICRO-GUIDE SYSTEM

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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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