The following data is part of a premarket notification filed by Meril Life Sciences Private Limited with the FDA for Aspiron(tm) Aspiration Catheter.
| Device ID | K190619 |
| 510k Number | K190619 |
| Device Name: | Aspiron(TM) Aspiration Catheter |
| Classification | Aspiration Thrombectomy Catheter |
| Applicant | Meril Life Sciences Private Limited Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala Vapi, IN 396191 |
| Contact | Utpal Thakor |
| Correspondent | H. Semih Oktay CardioMed Device Consultants, LLC 1783 Forest Drive, #254 Annapolis, MD 21401 |
| Product Code | QEZ |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-11 |
| Decision Date | 2019-04-29 |