FRANZ CATHETER— 510(k) K881853

Name: FDA 510(k) clearance K881853
Creator: U.S. Food and Drug Administration
Published: 1988-07-18

Substantially Equivalent

Ep Technologies, Inc.

FDA 510(k) clearance K881853 for FRANZ CATHETER, Substantially Equivalent on 1988-07-18. Applicant: Ep Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Ep Technologies, Inc.
Product code: Code DRF
Device class: Class 2
Regulation: 21 CFR 870.1220
Advisory panel: Cardiovascular
Date received: 1988-05-03
Decision date: 1988-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ep Technologies, Inc.

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K003452 — POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D2000-12-07
K940167 — DIAGNOSTIC I CATHETER1994-08-02
K940168 — DIAGNOSTIC II CATHETER1994-07-27

Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

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.