Baylis Medical Technologies Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3020689212 | 3020689212 | Baylis Medical Technologies Inc. | 1 | Y | 2026-01-01 | 11320 State Route 9 Champlain NY US 12919 |
| 3020968442 | 3020968442 | BAYLIS MEDICAL TECHNOLOGIES INC. | 1 | N | 2026-01-01 | 2645 Matheson Blvd E Mississauga Ontario CA L4W5S4 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 296315 | 1157505093 | K990284 | BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE | DXF | 2001-02-01 |
| 296315 | 1811811242 | K251158 | PowerWire® 14 Radiofrequency Guidewire Kit | PDU | 2025-09-11 |
| 296315 | 2070779572 | K232562 | PowerWire Radiofrequency Guidewire Kit | PDU | 2024-02-28 |
| 296315 | 1486569988 | K230571 | RFP-100A Connector Cable (Single Use) | DSA | 2023-05-30 |
| 296315 | 1763865561 | K151951 | Destino Reach | DYB | 2015-09-22 |
| 296315 | 1738855402 | K140406 | DESTINO TWIST, STEERABLE GUIDING SHEATH | DYB | 2014-04-17 |
| 296315 | 1358736166 | K132374 | BAYLIS MEDICAL RF PERFORATION PROBE V2.0 | GEI | 2013-08-30 |
| 296315 | 1144825111 | K120459 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | DYB | 2012-06-29 |
| 296315 | 1943015122 | K101615 | POWERWIRE RADIOFREQUENCY GUIDEWIRE | PDU | 2010-07-28 |
| 296315 | 1909477534 | K014075 | BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 | DQX | 2002-03-07 |
| 296315 | 1054625968 | K010265 | BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265 | GEI | 2001-04-09 |
| 296315 | 1107392518 | ||||
| 296315 | 1264096375 | ||||
| 296315 | 1345575744 | ||||
| 296315 | 1534218064 | ||||
| 296315 | 2016379000 |