FDA 510(k)

EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET

K-Number: K003627 · 2001-02-08

Decision Date2001-02-08

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET is the device name listed in this FDA 510(k) record. The listed applicant is Exelint International, Co.. It received FDA 510(k) clearance on 2001-02-08 under 510(k) number K003627. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET?

EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET is a medical device that received FDA 510(k) clearance on 2001-02-08. The listed applicant is Exelint International, Co.. The 510(k) number is K003627.

When did EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET receive FDA 510(k) clearance?

EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET received FDA 510(k) clearance on 2001-02-08, under 510(k) number K003627.

Who is the listed applicant for EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET?

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

What is the FDA product code for EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET?

The FDA product code for EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET is FMI.

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Other records listing Exelint International, Co. as applicant

K251089EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle K101309EXELINT ALUMINUM HUB BLUNT NEEDLES K020189EXEL BUTTERFLY SCALP VEIN SET K010197EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET K001496A.V. FISTULA NEEDLE

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.