CATHETER, SURFLO, I.V.— 510(k) K770422

Substantially Equivalent

Terumo America, Inc.

FDA 510(k) clearance K770422 for CATHETER, SURFLO, I.V., Substantially Equivalent on 1977-03-16. Applicant: Terumo America, Inc.. Device class: 1.

Clearance details

Applicant: Terumo America, Inc.
Product code: Code FOX
Device class: Class 1
Regulation: 21 CFR 880.6990
Advisory panel: General Hospital
Date received: 1977-03-07
Decision date: 1977-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FOX

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K961470 — PORT-A-POLE1996-07-22
K960027 — HIGH VOLUME I.V. & IRRIGATION TOWER1996-03-12
K952196 — IV POLE/STAND1995-07-31

More clearances from Terumo America, Inc.

K811523 — PLASMA FLEX1981-09-09
K802970 — TERUMO HOLLOW FIBER OXYGENATOR1981-01-22
K802122 — CLIRANS TH13 HOLLOW FIBER DIALYZER1980-12-18
K802441 — CLIRANS TH10 HOLLOW FIBER DIALYZER1980-12-18
K801192 — CLIRANS TE10 HOLLOW FIBER DIALYZER1980-08-12

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