The following data is part of a premarket notification filed by Centerline Biomedical, Inc. with the FDA for Intra-operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle.
| Device ID | K190106 |
| 510k Number | K190106 |
| Device Name: | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Centerline Biomedical, Inc. 10000 Cedar Ave Cleveland, OH 44106 |
| Contact | Vikash Goel |
| Correspondent | Lauren Smith JALEX Medical 30311 Clemens Rd Suite 5D Westlake, OH 44145 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-22 |
| Decision Date | 2019-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10843152102010 | K190106 | 000 |
| 00843152104000 | K190106 | 000 |
| 00843152100002 | K190106 | 000 |
| 10843152101037 | K190106 | 000 |
| 10843152101020 | K190106 | 000 |
| 10843152103000 | K190106 | 000 |