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FDA 510(k)

PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS

K-Number: K981368 · 1998-05-01

ApplicantCatheter Innovations, Inc.
Decision Date1998-05-01
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS is the device name listed in this FDA 510(k) record. The listed applicant is Catheter Innovations, Inc.. It received FDA 510(k) clearance on 1998-05-01 under 510(k) number K981368. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS?

PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS is a medical device that received FDA 510(k) clearance on 1998-05-01. The listed applicant is Catheter Innovations, Inc.. The 510(k) number is K981368.

When did PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS receive FDA 510(k) clearance?

PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS received FDA 510(k) clearance on 1998-05-01, under 510(k) number K981368.

Who is the listed applicant for PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS?

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

What is the FDA product code for PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS?

The FDA product code for PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS is FOZ.

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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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Other records listing Catheter Innovations, 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.

K021704VAXCEL PICC WITH PASV VALVE TECHNOLOGYK010349DUAL LUMEN MIDLINE CATHETERK003642PLACEMENT-PLUSK993860CATHETER INNOVATIONS IMPLANTABLE PORTK991897CATHETER INNOVATIONS IMPLANTABLE PORTK981382PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS

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Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, 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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