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FDA 510(k)

HEART CATH TRAY, STERILE, DISPOSABLE

K-Number: K981441 · 1998-07-10

ApplicantTrinity Laboratories, Inc.
Decision Date1998-07-10
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART CATH TRAY, STERILE, 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 1998-07-10 under 510(k) number K981441. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEART CATH TRAY, STERILE, DISPOSABLE?

HEART CATH TRAY, STERILE, DISPOSABLE is a medical device that received FDA 510(k) clearance on 1998-07-10. The listed applicant is Trinity Laboratories, Inc.. The 510(k) number is K981441.

When did HEART CATH TRAY, STERILE, DISPOSABLE receive FDA 510(k) clearance?

HEART CATH TRAY, STERILE, DISPOSABLE received FDA 510(k) clearance on 1998-07-10, under 510(k) number K981441.

Who is the listed applicant for HEART CATH TRAY, STERILE, 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 HEART CATH TRAY, STERILE, DISPOSABLE?

The FDA product code for HEART CATH TRAY, STERILE, DISPOSABLE is DQO.

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Other records listing Trinity Laboratories, Inc. as applicant

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K974238DENTAL 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, DISPOSABLEK964921BASIC BIOPSY TRAY. DISPOSABLE, STERILE

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Related Devices (Code: DQO)

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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