MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER— 510(k) K902370

Name: FDA 510(k) clearance K902370
Creator: U.S. Food and Drug Administration
Published: 1990-08-17

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K902370 for MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER, Substantially Equivalent on 1990-08-17. Applicant: Boston Scientific Corp. Device class: 2.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code FAH
Device class: Class 2
Regulation: 21 CFR 876.5520
Advisory panel: Gastroenterology, Urology
Date received: 1990-05-29
Decision date: 1990-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FAH

view all

K933957 — DILATING URETHRAL SOUND1993-11-17
K902124 — DOWD CATHETER1990-08-09
K831384 — COAXIAL BALLOON URETHRAL DILATOR1983-07-26

More clearances from Boston Scientific Corp

view all

K243245 — IceSeed 1.5 CX Straight Needle (H7493968333170) +2 more2024-10-18
K231328 — LUX-Dx II (M302); LUX-Dx II+ (M312)2023-08-19
K152853 — WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary2015-11-20
K150692 — AXIOS Stent with Electrocautery Enhanced Delivery System2015-08-05
K150303 — XXL Vascular Balloon Dilatation Catheter2015-06-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.