CATHETER, CARDIOVASCULAR, BALLOON TYPE— 510(k) K883852

Name: FDA 510(k) clearance K883852
Creator: U.S. Food and Drug Administration
Published: 1989-12-07

Substantially Equivalent

Wb Intl., Inc.

FDA 510(k) clearance K883852 for CATHETER, CARDIOVASCULAR, BALLOON TYPE, Substantially Equivalent on 1989-12-07. Applicant: Wb Intl., Inc.. Device class: 2.

Clearance details

Applicant: Wb Intl., Inc.
Product code: Code DXE
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 1988-09-13
Decision date: 1989-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXE

view all

K240078 — Fogarty Thru-Lumen Embolectomy Catheter2024-08-28
K241330 — Fogarty Fortis Arterial Embolectomy Catheter2024-07-02
K233819 — Fogarty Venous Thrombectomy Catheters2024-05-22
K233820 — Fogarty Arterial Embolectomy Catheter with Gate Valve2024-05-22
K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters2024-05-20

More clearances from Wb Intl., Inc.

view all

K885089 — SURGICAL GLOVES1989-06-22

Adverse events under product code DXE

product code DXE

Death: 27
Injury: 258
Malfunction: 2,266
Total: 2,551

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.