DAIG ELECTROPHYSIOLOGY CATHETER— 510(k) K894500

Clearance details

Applicant

Daig Corp.

Product code

Code DRF

Device class

Class 2

Regulation

21 CFR 870.1220

Advisory panel

Cardiovascular

Date received

1989-07-19

Decision date

1989-09-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Minnetonka, MN, US

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• K982299 — SPYGLASS 5 FR ANGIOGRAPHIC CATHETER1998-10-19
• K982187 — FAST-CATH INTRA-CARDIAC INTRODUCER1998-09-16
• K973840 — FAST-CATH (TM) INTRA-CARDIAC INTRODUCER1998-05-21

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 →

• Z-0177-2015 — St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353Class II·Terminated·St Jude Medical·20141014

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K894500.