The following data is part of a premarket notification filed by Act Medical, Inc. with the FDA for Endoscopic Catheter.
| Device ID | K953967 |
| 510k Number | K953967 |
| Device Name: | ENDOSCOPIC CATHETER |
| Classification | Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula |
| Applicant | ACT MEDICAL, INC. 100 BEAVER ST. Waltham, MA 02154 |
| Contact | Jenna Andelman |
| Correspondent | Jenna Andelman ACT MEDICAL, INC. 100 BEAVER ST. Waltham, MA 02154 |
| Product Code | ODD |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-22 |
| Decision Date | 1996-01-22 |