The following data is part of a premarket notification filed by Big Blue Biotech, Inc. with the FDA for Wiygul Catheter.
| Device ID | K202566 |
| 510k Number | K202566 |
| Device Name: | Wiygul Catheter |
| Classification | Catheter, Straight |
| Applicant | Big Blue Biotech, Inc. 690 Canton Street, Suite 302 Westwood, MA 02090 |
| Contact | Russ Olsen |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-09-04 |
| Decision Date | 2020-09-30 |