FLEX-TECH BALLOON DILATOR— 510(k) K926038

Name: FDA 510(k) clearance K926038
Creator: U.S. Food and Drug Administration
Published: 1993-10-25

Substantially Equivalent

Cape Tech Medical Products

FDA 510(k) clearance K926038 for FLEX-TECH BALLOON DILATOR, Substantially Equivalent on 1993-10-25. Applicant: Cape Tech Medical Products. Device class: 2.

Clearance details

Applicant: Cape Tech Medical Products
Product code: Code KNQ
Device class: Class 2
Regulation: 21 CFR 876.5365
Advisory panel: Gastroenterology, Urology
Date received: 1992-12-01
Decision date: 1993-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Falmouth, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Cape Tech Medical Products

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K926039 — GUIDE-TECH ENCAPSULATED GUIDEWIRE1993-08-05
K926040 — HELI-TECH RETRIEVAL BASKET1992-12-23

Adverse events under product code KNQ

product code KNQ

Malfunction: 1,844
Total: 1,844

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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