510(k) K803086 ยท LDF Electrode, Pacemaker, Temporary
MYOWIRE-ATEMPORARY CARDIAC PACING WIRE
| Applicant | Craig & Craig, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Jul 1, 1981 |
| Received | Dec 8, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K803086
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
CARDIAC PACING PACK, Pack Number DYNJ41223 Open, Classified |
LDF | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O;
2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH;
3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J; Open, Classified |
LDF | None listed |
| Jun 21, 2019 | Alto Development Corp A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)-
Temporary Pacing Electrode as follows:
021-001 MYO/Wire Ultra-Flex Monopolar (Wht.,2-0)
021-010 M Terminated |
LDF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.