The following data is part of a premarket notification filed by Adam Spence Corp. with the FDA for Ase Maxi-torque, Supple Flex Angiographic Catheters.
| Device ID | K950855 |
| 510k Number | K950855 |
| Device Name: | ASE MAXI-TORQUE, SUPPLE FLEX ANGIOGRAPHIC CATHETERS |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ADAM SPENCE CORP. 1746 RT. 34 P.O. BOX 1467 Wall, NJ 07719 |
| Contact | Adam Sanford |
| Correspondent | Adam Sanford ADAM SPENCE CORP. 1746 RT. 34 P.O. BOX 1467 Wall, NJ 07719 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-27 |
| Decision Date | 1995-05-30 |