The following data is part of a premarket notification filed by Washington Regulatory Services with the FDA for Angioscope For Pulmonary Artery Use.
| Device ID | K882658 |
| 510k Number | K882658 |
| Device Name: | ANGIOSCOPE FOR PULMONARY ARTERY USE |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | WASHINGTON REGULATORY SERVICES R.D. # 3 BOX 237 WELISEWITZ RD. Ringoes, NJ 08551 |
| Contact | Randolph L Cooke |
| Correspondent | Randolph L Cooke WASHINGTON REGULATORY SERVICES R.D. # 3 BOX 237 WELISEWITZ RD. Ringoes, NJ 08551 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-29 |
| Decision Date | 1989-01-26 |