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FDA 510(k)

SUCTION CATHETER KIT, STERILE, SINGLE-USE

K-Number: K951506 · 1995-07-03

ApplicantTrinity Laboratories, Inc.
Decision Date1995-07-03
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SUCTION CATHETER KIT, STERILE, SINGLE-USE 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 1995-07-03 under 510(k) number K951506. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUCTION CATHETER KIT, STERILE, SINGLE-USE?

SUCTION CATHETER KIT, STERILE, SINGLE-USE is a medical device that received FDA 510(k) clearance on 1995-07-03. The listed applicant is Trinity Laboratories, Inc.. The 510(k) number is K951506.

When did SUCTION CATHETER KIT, STERILE, SINGLE-USE receive FDA 510(k) clearance?

SUCTION CATHETER KIT, STERILE, SINGLE-USE received FDA 510(k) clearance on 1995-07-03, under 510(k) number K951506.

Who is the listed applicant for SUCTION CATHETER KIT, STERILE, SINGLE-USE?

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 SUCTION CATHETER KIT, STERILE, SINGLE-USE?

The FDA product code for SUCTION CATHETER KIT, STERILE, SINGLE-USE is BSY.

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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: BSY)

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.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., 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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