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FDA 510(k)

PARACENTESIS CATHETER DEVICE

K-Number: K974146 · 1998-01-28

ApplicantAllegiance Healthcare Corp.
Decision Date1998-01-28
Product CodeGCB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PARACENTESIS CATHETER DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Allegiance Healthcare Corp.. It received FDA 510(k) clearance on 1998-01-28 under 510(k) number K974146. The device is classified under product code GCB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARACENTESIS CATHETER DEVICE?

PARACENTESIS CATHETER DEVICE is a medical device that received FDA 510(k) clearance on 1998-01-28. The listed applicant is Allegiance Healthcare Corp.. The 510(k) number is K974146.

When did PARACENTESIS CATHETER DEVICE receive FDA 510(k) clearance?

PARACENTESIS CATHETER DEVICE received FDA 510(k) clearance on 1998-01-28, under 510(k) number K974146.

Who is the listed applicant for PARACENTESIS CATHETER DEVICE?

The FDA 510(k) record lists Allegiance Healthcare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARACENTESIS CATHETER DEVICE?

The FDA product code for PARACENTESIS CATHETER DEVICE is GCB.

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Other records listing Allegiance Healthcare Corp. 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.

K023673AIRLIFE DEMAND NASAL CANNULAK023419TRILAMINATE DRAPES/TIBURONK024120MODIFICATION TO TEMNO BIOPSY NEEDLESK024292MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIMK024102DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMK023425DRAPES WITH ABSORBENT REINFORCEMENT

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Related Devices (Code: GCB)

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.

K930568ADAIR/VERESS NEEDLE INTRODUCER SETMedical Dynamics, Inc.K923028TURKEL PNEUMOTHORAX KITSymbiosis Corp.K900374ADAIR/VERESS NEEDLE INTRODUCER SETMedical Dynamics, Inc.K854327SUBCUTANEOUS TUNNELING NEEDLES & HANDLESConcord Laboratories, Inc.K852428MANAN EPIDURAL NEEDLEManan Manufacturing Co., Inc.K780896NEEDLES, DESIGN CHANGE, IV CATHETERSJelco Laboratories

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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