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FDA 510(k)

PARACENTESIS NEEDLES/CANNULAS

K-Number: K945160 · 1994-11-14

ApplicantTri-Med Specialties, Inc.
Decision Date1994-11-14
Product CodeLRO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PARACENTESIS NEEDLES/CANNULAS is the device name listed in this FDA 510(k) record. The listed applicant is Tri-Med Specialties, Inc.. It received FDA 510(k) clearance on 1994-11-14 under 510(k) number K945160. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARACENTESIS NEEDLES/CANNULAS?

PARACENTESIS NEEDLES/CANNULAS is a medical device that received FDA 510(k) clearance on 1994-11-14. The listed applicant is Tri-Med Specialties, Inc.. The 510(k) number is K945160.

When did PARACENTESIS NEEDLES/CANNULAS receive FDA 510(k) clearance?

PARACENTESIS NEEDLES/CANNULAS received FDA 510(k) clearance on 1994-11-14, under 510(k) number K945160.

Who is the listed applicant for PARACENTESIS NEEDLES/CANNULAS?

The FDA 510(k) record lists Tri-Med Specialties, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARACENTESIS NEEDLES/CANNULAS?

The FDA product code for PARACENTESIS NEEDLES/CANNULAS is LRO.

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Other records listing Tri-Med Specialties, Inc. as applicant

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K971615PATTISON ESOPHAGEAL DILATORK970890#ES-32 SUCTION CATHETER 32 FR.K970982T-RX RETRIEVAL FORCEPSK942918TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETERK950574NEEDLE/CANNULAK934348TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FR

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Related Devices (Code: LRO)

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.

K213481Medline General Surgery TrayMedline Industries, Inc.K212258Medline Cardiovascular Procedure KitMedline Industries, Inc.K041080SURGICAL DRAPE KIT - D.I.R.R.A. SRLD.I.R.R.A. S.R.L.K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEBallard Medical ProductsK023276AMSINO TRACHEOSTOMY CARE TRAYAmsino International, Inc.K980137WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAYWorldwide Medical Technologies, LLC

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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