The following data is part of a premarket notification filed by Lucent Medical Systems with the FDA for Zortran Detector.
| Device ID | K000997 |
| 510k Number | K000997 |
| Device Name: | ZORTRAN DETECTOR |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | LUCENT MEDICAL SYSTEMS 135 LAKE ST. SOUTH # 250 Kirkland, WA 98033 |
| Contact | Cindy Pestka |
| Correspondent | Cindy Pestka LUCENT MEDICAL SYSTEMS 135 LAKE ST. SOUTH # 250 Kirkland, WA 98033 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-28 |
| Decision Date | 2000-09-07 |