The following data is part of a premarket notification filed by Cd Leycom Bv with the FDA for Cardiac Function Laboratory; Pressure Interface; Pressure / Volume Catheter.
| Device ID | K003020 |
| 510k Number | K003020 |
| Device Name: | CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | CD LEYCOM BV ARGONSTRAAT 116 Zoetermeer, NL 2718 Sp |
| Contact | Tim Lenihan |
| Correspondent | Tim Lenihan CD LEYCOM BV ARGONSTRAAT 116 Zoetermeer, NL 2718 Sp |
| Product Code | DQO |
| Subsequent Product Code | DRQ |
| Subsequent Product Code | DXO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-27 |
| Decision Date | 2001-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08717953256645 | K003020 | 000 |