PICC-FIX— 510(k) K911070

Name: FDA 510(k) clearance K911070
Creator: U.S. Food and Drug Administration
Published: 1991-07-05

Substantially Equivalent

Sorex Medical

FDA 510(k) clearance K911070 for PICC-FIX, Substantially Equivalent on 1991-07-05. Applicant: Sorex Medical. Device class: 1.

Clearance details

Applicant: Sorex Medical
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1991-03-11
Decision date: 1991-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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K941098 — SECURE-SITE1995-08-09
K943147 — STATLOCK CV1994-09-29

More clearances from Sorex Medical

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K923843 — FOGLESS1994-03-25
K913036 — PLUME MASTER1991-09-06
K911150 — SOREX SAFE-AIR1991-06-28
K910315 — PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K1991-04-05
K905572 — EDLICH WOUND MANAGEMENT TRAY1991-03-12

Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.