510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K172591Substantially Equivalent

Fixed Patient Leads ECG Cable (Model 3153)

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

K172591 is the FDA 510(k) clearance record for Fixed Patient Leads ECG Cable (Model 3153), a class II device, cleared for Boston Scientific Corporation on under FDA product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K172591.

Clearance record

Decision date
Received
(66 days to decision)
Product code
DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Regulation
21 CFR 870.2900
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific Corporation 4100 Hamline Ave. N, St Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DSA

Trailing 12 months
2 clearances under product code DSA in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260