Data / Medical devices / United States / Meril Inc
Meril Inc: FDA-registered device maker in Bethlehem, PA, United States, 4 510(k) clearances
Meril Inc is registered with the FDA (registration 3012167431) in Bethlehem, PA, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 29, 2019. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3012167431
- Address
- 2436 Emrick Boulevard, Bethlehem, PA, United States, 18020
- Owner or operator
- Meril Inc (10049695)
- Roles
- Complaint file establishment
- First device listed
- December 31, 2018
- Registered through
- 2026
- Brand names listed
- Aspiron(TM) Aspiration Catheter, MESIRE Light Guide Cable, MESIRE - Balloon Sinus Dilatation System, Mozec(TM) NC - Rx PTCA Balloon Dilatation Catheter, Mozec(TM) Rx PTCA Balloon Dilatation Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aspiration Thrombectomy Catheter | QEZ | 2 | Complaint file establishment | accessdata.fda.gov |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | Complaint file establishment | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Complaint file establishment | accessdata.fda.gov |
| Source, Carrier, Fiberoptic Light | EQH | 1 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 29, 2019 | K190619 | Aspiron(TM) Aspiration Catheter | QEZ | Substantially Equivalent | Meril Life Sciences Private Limited | accessdata.fda.gov |
| December 12, 2017 | K172737 | MESIRE - Balloon Sinus Dilatation System | LRC | Substantially Equivalent | M/S. Meril Life Sciences Private Limited | accessdata.fda.gov |
| July 30, 2016 | K160961 | Mozec NC-Rx PTCA Baloon Dilatation Catheter | LOX | Substantially Equivalent | Meril Life Sciences Private Limited | accessdata.fda.gov |
| December 24, 2013 | K131169 | MOZEC - RX PTCA BALLOON DILATATION CATHETER | LOX | Substantially Equivalent | Meril Life Sciences Private Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Source, Carrier, Fiberoptic Light
- All makers of Instrument, Ent Manual Surgical
- All makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous
- All makers of Aspiration Thrombectomy Catheter
Updated April 29, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.