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FDA 510(k)

PICC-FIX

K-Number: K911070 · 1991-07-05

ApplicantSorex Medical
Decision Date1991-07-05
Product CodeKMK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PICC-FIX is the device name listed in this FDA 510(k) record. The listed applicant is Sorex Medical. It received FDA 510(k) clearance on 1991-07-05 under 510(k) number K911070. The device is classified under product code KMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PICC-FIX?

PICC-FIX is a medical device that received FDA 510(k) clearance on 1991-07-05. The listed applicant is Sorex Medical. The 510(k) number is K911070.

When did PICC-FIX receive FDA 510(k) clearance?

PICC-FIX received FDA 510(k) clearance on 1991-07-05, under 510(k) number K911070.

Who is the listed applicant for PICC-FIX?

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

What is the FDA product code for PICC-FIX?

The FDA product code for PICC-FIX is KMK.

Other records listing Sorex Medical 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.

K923843FOGLESSK913036PLUME MASTERK911150SOREX SAFE-AIRK910315PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.KK905572EDLICH WOUND MANAGEMENT TRAYK903740TRACH-EZE

View all 9 devices →

Related Devices (Code: KMK)

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.

K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8FInterrad Medical, Inc.K981860A P HARNESSParaworks Enterprise, Ltd.K963365MULTI-PURPOSE MEDICAL TUBE HOLDERByrd Medical Devices, Inc.K941098SECURE-SITEOp-Co Medical Products , Ltd.K943147STATLOCK CVVenetec, Inc.K943047IV START KITSSterile Concepts, 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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