The following data is part of a premarket notification filed by Mercator Medsystems, Inc. with the FDA for Mercator Microsyringe Ii Infusion Catheter.
| Device ID | K062752 |
| 510k Number | K062752 |
| Device Name: | MERCATOR MICROSYRINGE II INFUSION CATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | MERCATOR MEDSYSTEMS, INC. 3077 TEAGARDEN STREET San Leandro, CA 94577 -5720 |
| Contact | Kirk Seward |
| Correspondent | Patricia L Murphy KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-09-14 |
| Decision Date | 2006-12-07 |
| Summary: | summary |