510(k) K992137 ยท GBM Catheter, Urethral
UROLOGICAL CATHETER
| Applicant | Apogee, Inc., Raleigh NC, US |
| Decision | Substantially Equivalent, Sep 3, 1999 |
| Received | Jun 24, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992137
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2008 | Apogee Medical, Inc Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1007, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder. Terminated |
GBM | None listed |
| Sep 21, 2008 | Apogee Medical, Inc Apogee Intermittent Catheter, 8 Fr 16", Catalog/Ref No. 1018, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder. Terminated |
GBM | None listed |
| Sep 21, 2008 | Apogee Medical, Inc Apogee Intermittent Catheter, 10 Fr 15", Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the bladder. Terminated |
GBM | None listed |
| Sep 21, 2008 | Apogee Medical, Inc Apogee Intermittent Catheter with Coude tip, 12 Fr 16", Catalog/Ref No. 1036, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the Terminated |
GBM | None listed |
| Sep 21, 2008 | Apogee Medical, Inc Apogee Intermittent Catheter with Coude tip, 14 Fr 16", Catalog/Ref No.1066, Sterile, Latex free. The device is intended to be used as a urinary incontinence device designed to drain urine from the b Terminated |
GBM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.