The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Fixed Patient Leads Ecg Cable (model 3153).
| Device ID | K172591 |
| 510k Number | K172591 |
| Device Name: | Fixed Patient Leads ECG Cable (Model 3153) |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | Boston Scientific Corporation 4100 Hamline Avenue North St. Paul, MN 55112 |
| Contact | Elizabeth A. Lisowski |
| Correspondent | Elizabeth A. Lisowski Boston Scientific Corporation 4100 Hamline Avenue North St. Paul, MN 55112 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-29 |
| Decision Date | 2017-11-03 |
| Summary: | summary |