CARDIO2 Cycle
FDA 510(k) K926233 · Ergometrix, Inc.
510(k) numberK926233
Submission
- Device name
- CARDIO2 Cycle
- Applicant
- Ergometrix, Inc.
Minneapolis, MN, US - Received
- December 11, 1992
- Decision date
- June 4, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KRI – Accessory Equipment, Cardiopulmonary Bypass
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.4200
- Specialty
- Cardiovascular
Other 510(k)s with product code KRI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K020365 | 3TM Myocardial Needle-Temperature ProbeKRI · Traditional | 3t Medical Systems, LLC | 05/03/2002SE |
| K992635 | Interface Module IdddKRI · Special | Stoeckert Instrumente | 12/20/1999SE |
| K990512 | Stockert Power Supply Unit for S3 ComponentsKRI · Traditional | Stoeckert Instrumente | 11/23/1999SE |
| K934782 | Ammex Tubing OrganizerKRI · Traditional | Ammex Cardiopulmonary Corp. | 11/18/1993SE |
| K922404 | Tube GripKRI · Traditional | Georgia Medical Products, Inc. | 11/23/1992SE |
| K892856 | Newmark(Tm) Coronary Artery Bypass Graft MarkersKRI · Traditional | Acacia Laboratories, Inc. | 11/08/1989SE |
| K884893 | Cardiotomy Reservoir Valve No. CRV-30 or PCRV-25KRI · Traditional | American Omni Medical, Inc. | 01/30/1989SE |
| K884640 | Cardioplegia Overpressure Valve CPOP-350 & 700KRI · Traditional | American Omni Medical, Inc. | 01/24/1989SE |
| K874605 | Hi-Lo Temp(R) Myocardial Temperature SensorKRI · Traditional | Mallinckrodt Critical Care | 02/02/1988SE |
| K874925 | Cpe 2000 Cardio Pulmonary ErgometerKRI · Traditional | Medical Graphics Corp. | 01/19/1988SE |
Questions and answers
When was CARDIO2 Cycle cleared by the FDA?
CARDIO2 Cycle (K926233) received a 510(k) decision of Substantially Equivalent on June 4, 1993, 175 days after the submission was received.
What is the product code of K926233?
The FDA product code is KRI – Accessory Equipment, Cardiopulmonary Bypass, a Class I (low risk) device regulated under 21 CFR 870.4200.