FDA 510(k)

REPAIR KITS FOR RIGHT ATRIAL CATH

K-Number: K832774 · 1984-01-03

Decision Date1984-01-03

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

REPAIR KITS FOR RIGHT ATRIAL CATH is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1984-01-03 under 510(k) number K832774. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPAIR KITS FOR RIGHT ATRIAL CATH?

REPAIR KITS FOR RIGHT ATRIAL CATH is a medical device that received FDA 510(k) clearance on 1984-01-03. The listed applicant is Quinton, Inc.. The 510(k) number is K832774.

When did REPAIR KITS FOR RIGHT ATRIAL CATH receive FDA 510(k) clearance?

REPAIR KITS FOR RIGHT ATRIAL CATH received FDA 510(k) clearance on 1984-01-03, under 510(k) number K832774.

Who is the listed applicant for REPAIR KITS FOR RIGHT ATRIAL CATH?

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

What is the FDA product code for REPAIR KITS FOR RIGHT ATRIAL CATH?

The FDA product code for REPAIR KITS FOR RIGHT ATRIAL CATH is LJS.

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Other records listing Quinton, Inc. as applicant

K032038PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 K021906QUINTON Q-CATH, MODEL 000460 K003576Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 K001492QUINTON Q-STRESS, MODEL 000483 K992908Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)K990866QUINTON MEDTRACK CR PLUS TREADMILL

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Related Devices (Code: LJS)

K260929Neonav ECG Tip Location SystemNavi Medical Technologies K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologySpectrum Vascular K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrAccess Vascular, Inc.K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.

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.