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FDA 510(k)

STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE

K-Number: K952058 · 1995-09-21

ApplicantTrinity Laboratories, Inc.
Decision Date1995-09-21
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Laboratories, Inc.. It received FDA 510(k) clearance on 1995-09-21 under 510(k) number K952058. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE?

STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE is a medical device that received FDA 510(k) clearance on 1995-09-21. The listed applicant is Trinity Laboratories, Inc.. The 510(k) number is K952058.

When did STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE receive FDA 510(k) clearance?

STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE received FDA 510(k) clearance on 1995-09-21, under 510(k) number K952058.

Who is the listed applicant for STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE?

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

What is the FDA product code for STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE?

The FDA product code for STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE is FOZ.

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Other records listing Trinity Laboratories, 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.

K981441HEART CATH TRAY, STERILE, DISPOSABLEK974238DENTAL TRAY, STERILE, DISPOSABLEK974286CIRCUMCISION TRAY, CAT. NO. 70340K972160CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TESTK970722EYE TRAYK965201O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE

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Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.

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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