The following data is part of a premarket notification filed by Adam Spencer Corp. with the FDA for Asc High Pressure Braided Tubes.
| Device ID | K964331 |
| 510k Number | K964331 |
| Device Name: | ASC HIGH PRESSURE BRAIDED TUBES |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ADAM SPENCER CORP. 19526 EAST LAKE DR. Miami, FL 33015 |
| Contact | Al Weisenborn |
| Correspondent | Al Weisenborn ADAM SPENCER CORP. 19526 EAST LAKE DR. Miami, FL 33015 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-30 |
| Decision Date | 1997-01-13 |
| Summary: | summary |