Data / Medical devices / United States / Insitu Technologies, Inc.
Insitu Technologies, Inc.: FDA-registered device maker in Saint Paul, MN, United States, 6 510(k) clearances
Insitu Technologies, Inc. is registered with the FDA (registration 2134244) in Saint Paul, MN, United States. It lists 8 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 26, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2134244
- FEI number
- 3003407487
- Address
- 1301 Corporate Center Dr Ste 160, Saint Paul, MN, United States, 55121
- Owner or operator
- INSITU TECHNOLOGIES, INC. (9032211)
- Roles
- Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- August 1, 2008
- Registered through
- 2027
- Brand names listed
- AaRiss DCB, Aaris, Aaris DCB Catheter, Arriva, Celosia, Radial, Rainbow, Silene and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Diagnostic | DQO | 2 | Repackager or relabeler | accessdata.fda.gov |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Coronary Covered Stent | NIV | f | Manufacturer for export | accessdata.fda.gov |
| Coronary Drug-Eluting Stent | NIQ | 3 | Repackager or relabeler | accessdata.fda.gov |
| Drug-Coated Peripheral Transluminal Angioplasty Catheter | PRC | 3 | Manufacturer for export | accessdata.fda.gov |
| Iliac Covered Stent, Arterial | PRL | 3 | Manufacturer for export | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Specification developer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| November 26, 2018 | K182699 | Selethru PTCA Balloon Dilatation Catheter | LOX | Substantially Equivalent | Kossel Medtech (Suzhou) Co., Ltd. | accessdata.fda.gov |
| March 4, 2013 | K123818 | URSA ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | Curative Medical Technology, Inc. | accessdata.fda.gov |
| January 29, 2010 | K090427 | URSA ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | Curative Medical Technology, Inc. | accessdata.fda.gov |
| June 7, 2006 | K060551 | BRIVANT GUIDEWIRE | DQX | Substantially Equivalent | Brivant Limited | accessdata.fda.gov |
| February 9, 2005 | K043525 | CATHETER INTRODUCER | DYB | Substantially Equivalent | Galt Medical Corp. | accessdata.fda.gov |
| June 16, 2000 | K000313 | TEARAWAY INTRODUCER SHEATH | DYB | Substantially Equivalent | Xentek Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Coronary Drug-Eluting Stent
- All makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous
- All makers of Drug-Coated Peripheral Transluminal Angioplasty Catheter
- All makers of Coronary Covered Stent
- All makers of Catheter, Intravascular, Diagnostic
- All makers of Introducer, Catheter
Updated November 26, 2018. 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.