Data / Medical devices / India / Meril Life Sciences Pvt. Ltd.
Meril Life Sciences Pvt. Ltd.: FDA-registered device maker in Vapi Gujarat, India, 4 510(k) clearances
Meril Life Sciences Pvt. Ltd. is registered with the FDA (registration 3009613036) in Vapi Gujarat, India. It lists 5 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 2, 2026.
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- FDA registration number
- 3009613036
- Address
- Bilakhia House, Survey No. 135/139 Muktanand Marg, Chala, Vapi Gujarat, India, 396191
- Owner or operator
- Meril Life Sciences Pvt. Ltd. (10046054)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 29, 2014
- Registered through
- 2026
- Brand names listed
- Aspiron(TM) Aspiration Catheter, MESIRE Light Guide Cable, MESIRE - Balloon Sinus Dilatation System, MESIRE Balloon Sinus Dilatation System, Mozec - Rx PTCA Balloon Dilatation Catheter, Mozec NC-Rx PTCA Balloon Dilatation Catheter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aspiration Thrombectomy Catheter | QEZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Manufacturer | accessdata.fda.gov |
| Source, Carrier, Fiberoptic Light | EQH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Syringe, Balloon Inflation, Exempt | PTM | 2 | Complaint file establishment, Manufacturer | 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 Catheters, Transluminal Coronary Angioplasty, Percutaneous
- All makers of Syringe, Balloon Inflation, Exempt
- All makers of Source, Carrier, Fiberoptic Light
- All makers of Instrument, Ent Manual Surgical
- 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.