Teleport Microcatheter
Catheter, Percutaneous
OrbusNeich Medical Trading Inc.
The following data is part of a premarket notification filed by Orbusneich Medical Trading Inc. with the FDA for Teleport Microcatheter.
Pre-market Notification Details
| Device ID | K182360 |
| 510k Number | K182360 |
| Device Name: | Teleport Microcatheter |
| Classification | Catheter, Percutaneous |
| Applicant | OrbusNeich Medical Trading Inc. 5363 NW 35th Avenue Fort Lauderdale, FL 33060 |
| Contact | John Pazienza |
| Correspondent | John Pazienza OrbusNeich Medical Trading Inc. 5363 NW 35th Avenue Fort Lauderdale, FL 33060 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-30 |
| Decision Date | 2018-11-09 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06934955943089 | K182360 | 000 |
| 06934955943072 | K182360 | 000 |
| 06934955943065 | K182360 | 000 |
| 06934955943058 | K182360 | 000 |
Trademark Results [Teleport Microcatheter]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TELEPORT MICROCATHETER 87952324 not registered Live/Pending |
ORBUSNEICH MEDICAL PTE. LTD. 2018-06-07 |
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