510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150235Substantially Equivalent

CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels

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

K150235 is the FDA 510(k) clearance record for CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels, a class II device, cleared for Boston Scientific Corporation on under FDA product code DRQ (Amplifier And Signal Conditioner, Transducer Signal). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show one recall naming K150235.

Clearance record

Decision date
Received
(79 days to decision)
Product code
DRQ Amplifier And Signal Conditioner, Transducer Signal
Regulation
21 CFR 870.2060
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific Corporation 55 Technology Dr., Lowell MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRQ

Trailing 12 months

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

FDA records show no clearances under product code DRQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRQ, 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