The following data is part of a premarket notification filed by Lazarus Effect, Inc with the FDA for Funnel Guide Catheter Model G1020608.
| Device ID | K102439 |
| 510k Number | K102439 |
| Device Name: | FUNNEL GUIDE CATHETER MODEL G1020608 |
| Classification | Catheter, Percutaneous |
| Applicant | LAZARUS EFFECT, INC 767 EL SOLYO HEIGHTS DR Felton, CA 95018 |
| Contact | Carrie Neuberger |
| Correspondent | Carrie Neuberger LAZARUS EFFECT, INC 767 EL SOLYO HEIGHTS DR Felton, CA 95018 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-26 |
| Decision Date | 2012-01-12 |
| Summary: | summary |