Cardioplegia Cooling & Admin. Sets
FDA 510(k) K811368 · Bentley Laboratories, Inc.
510(k) numberK811368
Submission
- Device name
- Cardioplegia Cooling & Admin. Sets
- Applicant
- Bentley Laboratories, Inc.
Mchenry, IL, US - Received
- May 14, 1981
- Decision date
- June 9, 1981
- 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
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 |
| K926233 | CARDIO2 CycleKRI · Traditional | Ergometrix, Inc. | 06/04/1993SE |
| 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 |
More from Mallinckrodt Critical Care
| 510(k) | Device | Decision |
|---|---|---|
| K931967 | HE-30 GoldDTR · Traditional | 07/13/1993SE |
| K913956 | Blood Cardioplegia Heat Exchanger, Model #HE-30DTN · Traditional | 01/17/1992SE |
| K913692 | Venous Reservoir Bag Model No. BMR-250(TM)DTN · Traditional | 11/15/1991SE |
| K903641 | Quick Prime Hemoconcen. No. HQ-7000 and CBP-7000QKDI · Traditional | 11/09/1990SE |
| K894826 | Univox W/Holders, Models Univox-Hl, HLB, HLFDTZ · Traditional | 02/28/1990SE |
| K874867 | Catr(Tm)-H Cardiotomy HolderKPI · Traditional | 02/02/1988SE |
| K874841 | Integrated Membrane Oxygenator W/Cardiotomy FilterDTZ · Traditional | 02/02/1988SE |
| K874618 | Baxter Accuport(Tm) Central Venous CatheterDQR · Traditional | 01/19/1988SE |
| K823359 | Oxygen Consumption Monitor #OCM-0100DRY · Traditional | 01/05/1983SE |
| K823273 | BOS-2S, Spiraflo Bubble Infant Oxygen.DTZ · Traditional | 01/05/1983SE |
Questions and answers
When was Cardioplegia Cooling & Admin. Sets cleared by the FDA?
Cardioplegia Cooling & Admin. Sets (K811368) received a 510(k) decision of Substantially Equivalent on June 9, 1981, 26 days after the submission was received.
What is the product code of K811368?
The FDA product code is KRI – Accessory Equipment, Cardiopulmonary Bypass, a Class I (low risk) device regulated under 21 CFR 870.4200.