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FDA 510(k)

CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL

K-Number: K914523 · 1992-01-10

ApplicantCatheter Research C/O Burditt, Bowles & Radzius
Decision Date1992-01-10
Product CodeDSS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL 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 1992-01-10 under 510(k) number K914523. The device is classified under product code DSS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL?

CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL is a medical device that received FDA 510(k) clearance on 1992-01-10. The listed applicant is Catheter Research C/O Burditt, Bowles & Radzius. The 510(k) number is K914523.

When did CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL receive FDA 510(k) clearance?

CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL received FDA 510(k) clearance on 1992-01-10, under 510(k) number K914523.

Who is the listed applicant for CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL?

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 VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL?

The FDA product code for CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL is DSS.

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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.

K924227CRI CYNOSAR CATHETERK924125CRI ELECTRONIC CONTROL SYSTEMK904785CRI CYNOSAR CATHETERK904787CRI STEERABLE CATHETER CONTROL SYSTEMK900320CRI CYNOSAR CATHETERK884337MICRO-GUIDE SYSTEM

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Related Devices (Code: DSS)

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.

K983744MCAS (MODULAR CLIP APPLIER SYSTEM)Applied Medical ResourcesK961333HEARTPORT MULTIFIRE CLIP APPLIERHeartport, Inc.K920104IDENTI LOOPS DEGANIA SILICONEPuritas Health Care, Inc.K920676RMI SOFCLAMPResearch Medical, Inc.K901303HORIZON SURGICAL LIGATING AND MARKING CLIPHorizon Surgical, Inc.K883909SURGICAL SPRING CLIPSApplied Vascular Devices, 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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