Data / Medical devices / United States / VectraCor, Inc.
VectraCor, Inc.: FDA-registered device maker in Maple Grove, MN, United States, 1 510(k) clearance
VectraCor, Inc. is registered with the FDA (registration 2133542) in Maple Grove, MN, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 28, 2003. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2133542
- FEI number
- 1000520092
- Address
- 6901 E. Fish Lake Road Suite 190, Maple Grove, MN, United States, 55369
- Owner or operator
- VectraCor, Inc. (10038931)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- December 31, 2015
- Registered through
- 2026
- Brand names listed
- 3L Calibration Syringe, Electrode, Mouth Tube, Nose Clips
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calibrator, Volume, Gas | BXW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clip, Nose | BXJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | 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 |
|---|---|---|---|---|---|---|
| March 28, 2003 | K030073 | VERMED A10021 RESTING EKG TAB ELECTRODE | DRX | Substantially Equivalent | Vermont Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 16, 2012 | 61282 | Not yet classified | Terminated | QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured for QRS Diagnostic, 14755 27th Ave North, Plymouth, MN 55447 USA. Product Usage: The Universal ECG is an Electrocardiograph Diagno | QRS Diagnostic has initiated a recall involving Universal ECG 12 Lead IEC ECG Devices. This recall has been initiated because the chest lead wires on these devices may have been improperly labeled. Incorrect labeling of the lead wires could result in improper lead wire placement on the patient which may result in inaccurate waveforms being displayed to the u | accessdata.fda.gov |
Compare with other makers
- All makers of Clip, Nose
- All makers of Electrode, Electrocardiograph
- All makers of Mouthpiece, Breathing
- All makers of Calibrator, Volume, Gas
Updated March 23, 2012. 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.