510(k) K945229 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Aug 8, 1995 |
| Received | Oct 26, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945229
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2018 | Arrow International Inc ARROW Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm
Product Code: AI-06210-S
Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studie Terminated |
DRF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.