The following data is part of a premarket notification filed by Cardiovascular Imaging Systems, Inc. with the FDA for Automatic Pull Back Device.
| Device ID | K933517 |
| 510k Number | K933517 |
| Device Name: | AUTOMATIC PULL BACK DEVICE |
| Classification | Wire, Guide, Catheter |
| Applicant | CARDIOVASCULAR IMAGING SYSTEMS, INC. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 |
| Contact | Yue-teh Jang |
| Correspondent | Yue-teh Jang CARDIOVASCULAR IMAGING SYSTEMS, INC. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-20 |
| Decision Date | 1993-10-15 |