Data / Medical devices / Adjunctive Predictive Cardiovascular Indicator
Adjunctive Predictive Cardiovascular Indicator (QAQ): 8 FDA-registered makers in 6 countries
8 establishments in 6 countries are registered with the FDA to make Adjunctive Predictive Cardiovascular Indicator (product code QAQ, Class 2, 21 CFR 870.2210). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on May 15, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QAQ
- Device class
- 2
- Regulation
- 870.2210
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| China | 1 |
| Mexico | 1 |
| Dominican Republic | 1 |
| France | 1 |
| Malaysia | 1 |
Makers of Adjunctive Predictive Cardiovascular Indicator
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson And Company | Irvine, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BENCHMARK ELECTRONICS San Jorge | Tlajomulco de Zuniga Jalisco, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benchmark Electronics, Inc. | Winona, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG | HAINA San Cristobal, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences Technology Sarl | Anasco, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Implicity | Paris 1er Arrondissement, France | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Supercomal Medical Products, Sdn Bhd | SUNGAI PETANI Kedah, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 15, 2025. 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.