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FDA 510(k)

ISOLATE INFUSION CATHETR SYSTEM

K-Number: K913517 · 1991-11-05

ApplicantLake Region Mfg., Inc.
Decision Date1991-11-05
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ISOLATE INFUSION CATHETR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lake Region Mfg., Inc.. It received FDA 510(k) clearance on 1991-11-05 under 510(k) number K913517. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOLATE INFUSION CATHETR SYSTEM?

ISOLATE INFUSION CATHETR SYSTEM is a medical device that received FDA 510(k) clearance on 1991-11-05. The listed applicant is Lake Region Mfg., Inc.. The 510(k) number is K913517.

When did ISOLATE INFUSION CATHETR SYSTEM receive FDA 510(k) clearance?

ISOLATE INFUSION CATHETR SYSTEM received FDA 510(k) clearance on 1991-11-05, under 510(k) number K913517.

Who is the listed applicant for ISOLATE INFUSION CATHETR SYSTEM?

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

What is the FDA product code for ISOLATE INFUSION CATHETR SYSTEM?

The FDA product code for ISOLATE INFUSION CATHETR SYSTEM is DQY.

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Other records listing Lake Region Mfg., Inc. as applicant

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Related Devices (Code: DQY)

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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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