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FDA 510(k)

PRUITT IRRIGATION AND OCCLUSION CATHETER

K-Number: K844094 · 1984-11-29

ApplicantBionomy, Inc.
Decision Date1984-11-29
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRUITT IRRIGATION AND OCCLUSION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Bionomy, Inc.. It received FDA 510(k) clearance on 1984-11-29 under 510(k) number K844094. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRUITT IRRIGATION AND OCCLUSION CATHETER?

PRUITT IRRIGATION AND OCCLUSION CATHETER is a medical device that received FDA 510(k) clearance on 1984-11-29. The listed applicant is Bionomy, Inc.. The 510(k) number is K844094.

When did PRUITT IRRIGATION AND OCCLUSION CATHETER receive FDA 510(k) clearance?

PRUITT IRRIGATION AND OCCLUSION CATHETER received FDA 510(k) clearance on 1984-11-29, under 510(k) number K844094.

Who is the listed applicant for PRUITT IRRIGATION AND OCCLUSION CATHETER?

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

What is the FDA product code for PRUITT IRRIGATION AND OCCLUSION CATHETER?

The FDA product code for PRUITT IRRIGATION AND OCCLUSION CATHETER is GBX.

Related Clinical Trials

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.

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Other records listing Bionomy, Inc. 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.

K851101BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SETK832023EMBOLECTOMY CATHETERK812111PRUITT ARTERIAL OCCLUSION CHOLANG. CATHK811276OCCLUSION CATHETER

Related Devices (Code: GBX)

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.

K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLCK052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.K043515GRAFTSAVERVescare, Inc.K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.K000704DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.K974233LYSONIX IRRIGATION SYSTEMLysonix, 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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