The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Mullins-x Ptv Catheter.
Device ID | K102473 |
510k Number | K102473 |
Device Name: | MULLINS-X PTV CATHETER |
Classification | Pulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter |
Applicant | NUMED, INC. 2880 MAIN ST. Hopkinton, NY 12965 |
Contact | Nichelle Laflesh |
Correspondent | Nichelle Laflesh NUMED, INC. 2880 MAIN ST. Hopkinton, NY 12965 |
Product Code | OMZ |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-30 |
Decision Date | 2010-12-09 |
Summary: | summary |