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FDA 510(k)

IMPACT TURBO CATH

K-Number: K851611 · 1985-06-05

ApplicantImpact Instrumentation, Inc.
Decision Date1985-06-05
Product CodeJOL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IMPACT TURBO CATH is the device name listed in this FDA 510(k) record. The listed applicant is Impact Instrumentation, Inc.. It received FDA 510(k) clearance on 1985-06-05 under 510(k) number K851611. The device is classified under product code JOL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPACT TURBO CATH?

IMPACT TURBO CATH is a medical device that received FDA 510(k) clearance on 1985-06-05. The listed applicant is Impact Instrumentation, Inc.. The 510(k) number is K851611.

When did IMPACT TURBO CATH receive FDA 510(k) clearance?

IMPACT TURBO CATH received FDA 510(k) clearance on 1985-06-05, under 510(k) number K851611.

Who is the listed applicant for IMPACT TURBO CATH?

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

What is the FDA product code for IMPACT TURBO CATH?

The FDA product code for IMPACT TURBO CATH is JOL.

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Other records listing Impact Instrumentation, 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.

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Related Devices (Code: JOL)

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.

K051370STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014Baxter Healthcare CorpK000266PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATIONPrimary Care Solutions, Inc.K000265PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATIONPrimary Care Solutions, Inc.K003402WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATIONWelcon, Inc.K994321STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USPAutomatic Liquid Packaging, Inc.K974758HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLEHydrox Laboratories

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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