510(k) K153778 ยท KRD Device, Vascular, For Promoting Embolization
Nester Embolization Coils, Tornado Embolization Coils
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, May 19, 2016 |
| Received | Dec 31, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153778
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2022 | Cook Incorporated Nester Embolization Microcoil
RPN GPN
MWCE-18-5-2-NESTER G52733
MWCE-18-5-3-NESTER G52734
MWCE-18-7-3-NESTER-01 G47338
MWCE-18-7-2-NESTER-01 G47337
MWCE-18-7-5-NES Open, Classified |
KRD | None listed |
| May 5, 2022 | Cook Incorporated Tornado Embolization Microcoil,
RPN GPN
MWCE-18S-5/2-TORNADO G08356
MWCE-18S-6/2-TORNADO G08259
MWCE-18S-3/2-TORNADO-01 G47416
MWCE-18S-4/2-TORNADO-01 G47417 Open, Classified |
KRD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.