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FDA 510(k)

SAFE-CATH

K-Number: K960764 · 1997-04-24

ApplicantScientific Device Manufacturer, LLC
Decision Date1997-04-24
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFE-CATH is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Device Manufacturer, LLC. It received FDA 510(k) clearance on 1997-04-24 under 510(k) number K960764. 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 SAFE-CATH?

SAFE-CATH is a medical device that received FDA 510(k) clearance on 1997-04-24. The listed applicant is Scientific Device Manufacturer, LLC. The 510(k) number is K960764.

When did SAFE-CATH receive FDA 510(k) clearance?

SAFE-CATH received FDA 510(k) clearance on 1997-04-24, under 510(k) number K960764.

Who is the listed applicant for SAFE-CATH?

The FDA 510(k) record lists Scientific Device Manufacturer, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFE-CATH?

The FDA product code for SAFE-CATH is FOZ.

Other records listing Scientific Device Manufacturer, LLC 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.

K960431PRESSURE STOPCOCK/MANIFOLDK961290IUP - TIP TRANS, IUP - PROXI TRANSK960430CONTROL SYRINGEK960917PERCUGLIDEK952579TOCO TRANSDUCER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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