Data / Medical devices / System, Balloon, Intra-Aortic And Control
System, Balloon, Intra-Aortic And Control (DSP): 15 FDA-registered makers in 6 countries
15 establishments in 6 countries are registered with the FDA to make System, Balloon, Intra-Aortic And Control (product code DSP, Class 2, 21 CFR 870.3535). 7 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 162 510(k) clearances under this code, the latest on March 26, 2025, and lists 62 recall events (23 Class I). FDA data exported November 2, 2026.
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- Product code
- DSP
- Device class
- 2
- Regulation
- 870.3535
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Germany | 2 |
| Mexico | 1 |
| China | 1 |
| India | 1 |
| Japan | 1 |
Makers of System, Balloon, Intra-Aortic And Control
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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
| Arrow Internacional de Chihuahua S.A. de C.V. | Chihuahua, Mexico | Exporter to the US, Manufacturer, Repackager or relabeler | 6 | April 9, 2020 | 0 | 0 | 0 | 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 | |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dolphin Life Science (india) LLP | Surat Gujarat, India | Contract manufacturer, Contract sterilizer | 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 | |
| Pulsion Medical Systems Se | Aschheim, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medizin Systeme Boeblingen GmbH | BOEBLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tokai Medical Products | Toki-City Gifu, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 26, 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.