The following data is part of a premarket notification filed by Cd Leycom Bv with the FDA for Cd Leycom 7 Fr Pressure/volume Catheter (10 Mm Electrode Spacing) Pressure/volume Combination Catheter With Lumen.
| Device ID | K030524 |
| 510k Number | K030524 |
| Device Name: | CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN |
| Classification | Catheter, Ultrasound, Intravascular |
| 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 | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-19 |
| Decision Date | 2003-03-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08719327737347 | K030524 | 000 |
| 08719327737330 | K030524 | 000 |
| 08719327737323 | K030524 | 000 |