Newmark(Tm) Coronary Artery Bypass Graft Markers
FDA 510(k) K892856 · Acacia Laboratories, Inc.
510(k) numberK892856
Submission
- Device name
- Newmark(Tm) Coronary Artery Bypass Graft Markers
- Applicant
- Acacia Laboratories, Inc.
Santa Ana, CA, US - Received
- April 18, 1989
- Decision date
- November 8, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRI – Accessory Equipment, Cardiopulmonary Bypass
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.4200
- Specialty
- Cardiovascular
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| 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 |
| K926233 | CARDIO2 CycleKRI · Traditional | Ergometrix, Inc. | 06/04/1993SE |
| K922404 | Tube GripKRI · Traditional | Georgia Medical Products, Inc. | 11/23/1992SE |
| 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 |
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| K913408 | Sterile Plastic DrapeKKX · Traditional | 03/12/1992SE |
| K901761 | Sterile Suction Tubing SetBYY · Traditional | 05/07/1990SE |
| K892804 | Newchill(Tm) Cardiac InsulatorDWS · Traditional | 07/14/1989SE |
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Questions and answers
When was Newmark(Tm) Coronary Artery Bypass Graft Markers cleared by the FDA?
Newmark(Tm) Coronary Artery Bypass Graft Markers (K892856) received a 510(k) decision of Substantially Equivalent on November 8, 1989, 204 days after the submission was received.
What is the product code of K892856?
The FDA product code is KRI – Accessory Equipment, Cardiopulmonary Bypass, a Class I (low risk) device regulated under 21 CFR 870.4200.