510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K891013Substantially Equivalent

Medtronic Intravascular Blood Gas Monitoring

Medtronic, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891013 is the FDA 510(k) clearance record for MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING, a class II device, cleared for Medtronic Vascular on under FDA product code CCC (Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K891013.

Clearance record

Decision date
Received
(155 days to decision)
Product code
CCC Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
Regulation
21 CFR 868.1150
Device class
Class II
Review panel
Anesthesiology
Applicant
Medtronic Vascular 7000 Central Ave., NE, Minneapolis MN
Third party review
No

Clearances, product code CCC

Trailing 12 months

FDA records hold no clearances under product code CCC in the trailing twelve months.

FDA records show no clearances under product code CCC in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CCC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260