Data / Medical devices / India / Angiplast Pvt. Ltd.
Angiplast Pvt. Ltd.: FDA-registered device maker in Kheda Gujarat, India, 1 510(k) clearance
Angiplast Pvt. Ltd. is registered with the FDA (registration 3027645738) in Kheda Gujarat, India. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 5, 2002. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3027645738
- Address
- Survey No. 589/1, 590 at Village Vasna Bujarg Dholka Road, Kheda Gujarat, India, 387411
- Owner or operator
- Angiplast Pvt. Ltd. (10029529)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 27, 2009
- Registered through
- 2027
- Brand names listed
- B-HEX Pupil Expander, ILLUMINATED YANKAUER SUCKER, Kentex Mucus Extrator, URO URINARY SUSPENSORY SYSTEM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Catheters, Suction, Tracheobronchial | BSY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Clip, Iris Retractor | HOC | 1 | Contract manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| March 5, 2002 | K012189 | ANGELTOUCH VENTED IV ADMINISTRATION SET | LHI | Substantially Equivalent | Angiplast Private , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Oxygen
- All makers of Catheter And Tip, Suction
- All makers of Bag, Urine Collection, Leg, For External Use, Non-Sterile
- All makers of Clip, Iris Retractor
- All makers of Catheters, Suction, Tracheobronchial
- All makers of Mask, Oxygen, Non-Rebreathing
Updated March 5, 2002. 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.