MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER — Astra Tech, Inc. (510(k) K012374)
MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER — Astra Tech, Inc. (510(k) K012374) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER; Applicant: Astra Tech, Inc.; Clearance track: 510(k).
| Device name | MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER |
|---|---|
| Applicant | Astra Tech, Inc. |
| Clearance track | 510(k) |
| Submission number | K012374 |
| Decision | Substantially Equivalent |
| Decision date | 2001-08-23 |
| Date received | 2001-07-26 |
| Product code | GBM |
| Device class | 2 |
| Medical specialty | Gastroenterology, Urology |
| Applicant location | MA, US |
| Source | openFDA device |
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