510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K023337Substantially Equivalent

Cre Pulmonary Balloon Dilatation Catheter, Models K00550300, M00550310, M00550320, M00550330, M00550340, M00550350

Boston Scientific Corporation, Natick, MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023337 is the FDA 510(k) clearance record for CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350, a class II device, cleared for Boston Scientific Corp on under FDA product code KTI (Bronchoscope Accessory). FDA's definition for product code KTI reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K023337.

Clearance record

Decision date
Received
(42 days to decision)
Product code
KTI Bronchoscope Accessory
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Boston Scientific Corp One Boston Scientific Pl., Natick, MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KTI

Trailing 12 months
4 clearances under product code KTI in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KTI, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20261
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260