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FDA 510(k)

HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES

K-Number: K851236 · 1985-07-26

ApplicantInfarkem Corp.
Decision Date1985-07-26
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Infarkem Corp.. It received FDA 510(k) clearance on 1985-07-26 under 510(k) number K851236. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES?

HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES is a medical device that received FDA 510(k) clearance on 1985-07-26. The listed applicant is Infarkem Corp.. The 510(k) number is K851236.

When did HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES receive FDA 510(k) clearance?

HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES received FDA 510(k) clearance on 1985-07-26, under 510(k) number K851236.

Who is the listed applicant for HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES?

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

What is the FDA product code for HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES?

The FDA product code for HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES is FJK.

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Other records listing Infarkem Corp. 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.

K852606FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20)K851336IV/0165 INFUSION SET

Related Devices (Code: FJK)

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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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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