Modified Prostatic Urethroplasty Balloon Catheter
FDA 510(k) K902370 · Boston Scientific Corp
510(k) numberK902370
Submission
- Device name
- Modified Prostatic Urethroplasty Balloon Catheter
- Applicant
- Boston Scientific Corp
Watertown, MA, US - Received
- May 29, 1990
- Decision date
- August 17, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FAH – Dilator, Urethral, Mechanical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5520
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Modified Prostatic Urethroplasty Balloon Catheter cleared by the FDA?
Modified Prostatic Urethroplasty Balloon Catheter (K902370) received a 510(k) decision of Substantially Equivalent on August 17, 1990, 80 days after the submission was received.
What is the product code of K902370?
The FDA product code is FAH – Dilator, Urethral, Mechanical, a Class II (moderate risk) device regulated under 21 CFR 876.5520.