The following data is part of a premarket notification filed by Cd Leycom Bv with the FDA for Cd Leycom Pressure/volume Catheters.
| Device ID | K031599 |
| 510k Number | K031599 |
| Device Name: | CD LEYCOM PRESSURE/VOLUME CATHETERS |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | CD LEYCOM BV ARGONSTRAAT 116 Zoetermeer, NL 2718 Sp |
| Contact | T. Lopes |
| Correspondent | T. Lopes CD LEYCOM BV ARGONSTRAAT 116 Zoetermeer, NL 2718 Sp |
| Product Code | DQO |
| Subsequent Product Code | DRO |
| Subsequent Product Code | DXO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-21 |
| Decision Date | 2003-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08719327737316 | K031599 | 000 |
| 08719327737309 | K031599 | 000 |