The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Percutaneous Pigtail Suprapublic Catheter Set.
| Device ID | K852287 |
| 510k Number | K852287 |
| Device Name: | PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET |
| Classification | Catheter, Suprapubic (and Accessories) |
| Applicant | COOK OB/GYN 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Contact | Dexter J Elkins |
| Correspondent | Dexter J Elkins COOK OB/GYN 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-29 |
| Decision Date | 1985-08-08 |