Holder for BOS-10, 10S 5S
FDA 510(k) K841812 · American Bentley
510(k) numberK841812
Submission
- Device name
- Holder for BOS-10, 10S 5S
- Applicant
- American Bentley
Mchenry, IL, US - Received
- May 1, 1984
- Decision date
- June 11, 1984
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K872896 | Umbilical Artery Oxygen Probe Model UAP-100CCE · Traditional | 02/12/1988SE |
| K873923 | Integrated Membrane Oxygenator W/Cardiotomy FilterDTZ · Traditional | 11/06/1987SE |
| K872167 | Cardiotomy/Mediastinal Auto. Reservoir CATR-3500DTP · Traditional | 09/01/1987SE |
| K870804 | Cardioplegia Heat Exchanger Model No. HE-100DTR · Traditional | 09/01/1987SE |
| K872133 | Oxygenator Model No. Bentley 5 PlusDTZ · Traditional | 08/24/1987SE |
| K870911 | Indwelling Blood Carbondioxide Partial Pres. AnalyCCC · Traditional | 05/29/1987SE |
| K870269 | Electrosurgical Meniscus Cutter (Emc) Mod. AMC-100GEI · Traditional | 03/09/1987SE |
| K863249 | Oxygenator Model No. BENTLEY-10 PlusDTZ · Traditional | 10/20/1986SE |
| K861641 | Heparin-Coated Extracorporeal CircuitsDTZ · Traditional | 09/29/1986SE |
| K862549 | Arterial Blood Filter Holder Model No. Af-HeKRI · Traditional | 07/15/1986SE |
Questions and answers
When was Holder for BOS-10, 10S 5S cleared by the FDA?
Holder for BOS-10, 10S 5S (K841812) received a 510(k) decision of Substantially Equivalent on June 11, 1984, 41 days after the submission was received.
What is the product code of K841812?
The FDA product code is KRI – Accessory Equipment, Cardiopulmonary Bypass, a Class I (low risk) device regulated under 21 CFR 870.4200.