510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912428Substantially Equivalent

Pb3300 Sensing Catheter for Continuous Measurement

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

K912428 is the FDA 510(k) clearance record for PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT, a class II device, cleared for Puritan Bennett Corp. on under FDA product code CBZ (Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K912428.

Clearance record

Decision date
Received
(70 days to decision)
Product code
CBZ Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
Regulation
21 CFR 868.1170
Device class
Class II
Review panel
Anesthesiology
Applicant
Puritan Bennett Corp. 6088 Corte Del Cedro, Carlsbad CA
510(k) summary
Statement
Third party review
No

Clearances, product code CBZ

Trailing 12 months

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

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