The following data is part of a premarket notification filed by Philips Image Guided Therapy Corporation with the FDA for Reconnaissance Pv .018 Otw Digital Ivus Catheter.
| Device ID | K200410 |
| 510k Number | K200410 |
| Device Name: | Reconnaissance PV .018 OTW Digital IVUS Catheter |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | Philips Image Guided Therapy Corporation 3721 Valley Centre Drive Ste 500 San Diego, CA 92130 |
| Contact | Mary Stanners |
| Correspondent | Mary Stanners Philips Image Guided Therapy Corporation 3721 Valley Centre Drive Ste 500 San Diego, CA 92130 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-19 |
| Decision Date | 2020-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225003067 | K200410 | 000 |