Data / Medical devices / System, Balloon, Intra-Aortic And Control / United States
FDA-registered makers of System, Balloon, Intra-Aortic And Control in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make System, Balloon, Intra-Aortic And Control (product code DSP). 6 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- System, Balloon, Intra-Aortic And Control
- Product code
- DSP
- Country
- United States
Makers of System, Balloon, Intra-Aortic And Control in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | Chelmsford, MA, United States | Manufacturer | 13 | March 26, 2025 | 0 | 3 | 1 | api.fda.gov |
| Arrow International LLC (subsidiary of Teleflex Incorporated) | Morrisville, NC, United States | Complaint file establishment, Specification developer | 12 | August 30, 2023 | 0 | 2 | 2 | api.fda.gov |
| Datascope Corp. | Mahwah, NJ, United States | Manufacturer | 7 | May 31, 2018 | 0 | 36 | 19 | api.fda.gov |
| Datascope Corp. | Fairfield, NJ, United States | Manufacturer | 5 | December 12, 2013 | 0 | 13 | 0 | api.fda.gov |
| Arrow International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 1 | March 31, 2017 | 0 | 5 | 1 | api.fda.gov |
| Insightra Medical, Inc. | Clarksville, TN, United States | Complaint file establishment, Specification developer | 1 | January 12, 2009 | 0 | 1 | 0 | api.fda.gov |
| Airgas Therapeutics LLC | Plumsteadville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Datascope Corp | Wayne, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing, Inc. | Brea, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.