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FDA 510(k)

MERIT HI-FLEX(TM)

K-Number: K883718 · 1989-01-30

ApplicantMerit Medical Systems, Inc.
Decision Date1989-01-30
Product CodeFPK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MERIT HI-FLEX(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 1989-01-30 under 510(k) number K883718. The device is classified under product code FPK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MERIT HI-FLEX(TM)?

MERIT HI-FLEX(TM) is a medical device that received FDA 510(k) clearance on 1989-01-30. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K883718.

When did MERIT HI-FLEX(TM) receive FDA 510(k) clearance?

MERIT HI-FLEX(TM) received FDA 510(k) clearance on 1989-01-30, under 510(k) number K883718.

Who is the listed applicant for MERIT HI-FLEX(TM)?

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

What is the FDA product code for MERIT HI-FLEX(TM)?

The FDA product code for MERIT HI-FLEX(TM) is FPK.

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Related Devices (Code: FPK)

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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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