The following data is part of a premarket notification filed by Arteria Medical Science, Inc. with the FDA for Parodi Catheter For Angiography (parca).
| Device ID | K001917 |
| 510k Number | K001917 |
| Device Name: | PARODI CATHETER FOR ANGIOGRAPHY (PARCA) |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | ARTERIA MEDICAL SCIENCE, INC. P.O. BOX 3515 Redmond, WA 98073 -3515 |
| Contact | Steve Chernoff |
| Correspondent | Steve Chernoff ARTERIA MEDICAL SCIENCE, INC. P.O. BOX 3515 Redmond, WA 98073 -3515 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-23 |
| Decision Date | 2001-06-06 |