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FDA 510(k)

GESCO PER-Q-CATH PICC CATHETERS

K-Number: K971990 · 1997-11-07

ApplicantBard Access Systems, Inc.
Decision Date1997-11-07
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GESCO PER-Q-CATH PICC CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc.. It received FDA 510(k) clearance on 1997-11-07 under 510(k) number K971990. 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 GESCO PER-Q-CATH PICC CATHETERS?

GESCO PER-Q-CATH PICC CATHETERS is a medical device that received FDA 510(k) clearance on 1997-11-07. The listed applicant is Bard Access Systems, Inc.. The 510(k) number is K971990.

When did GESCO PER-Q-CATH PICC CATHETERS receive FDA 510(k) clearance?

GESCO PER-Q-CATH PICC CATHETERS received FDA 510(k) clearance on 1997-11-07, under 510(k) number K971990.

Who is the listed applicant for GESCO PER-Q-CATH PICC CATHETERS?

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

What is the FDA product code for GESCO PER-Q-CATH PICC CATHETERS?

The FDA product code for GESCO PER-Q-CATH PICC CATHETERS is FOZ.

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Other records listing Bard Access Systems, Inc. as applicant

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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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