Cardiotomy Filter
FDA 510(k) K830634 · Texas Medical Products, Inc.
510(k) numberK830634
Submission
- Device name
- Cardiotomy Filter
- Applicant
- Texas Medical Products, Inc.
Mchenry, IL, US - Received
- March 1, 1983
- Decision date
- June 30, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOD – Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4270
- Specialty
- Cardiovascular
Other 510(k)s with product code JOD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993060 | Gas FilterJOD · Traditional | Olson Medical Sales, Inc. | 03/28/2000SE |
| K890504 | Cardiotomy/Autotransfusion/Pleural Drainage VenousJOD · Traditional | Gish Biomedical, Inc. | 03/10/1989SE |
| K875095 | Pall Cardioplegia Plus Filter W/Posidyne MembraneJOD · Traditional | Pall Biomedical Products Co. | 02/29/1988SE |
| K874405 | Pall Stat Prime(Tm) Blood Filter for Extra. UseJOD · Traditional | Pall Biomedical Products Co. | 12/30/1987SE |
| K855067 | Swank Cardiotomy Suction Line Blood Filter CA100JOD · Traditional | Cobe Laboratories, Inc. | 02/26/1986SE |
| K841958 | Cardio Metrics Cardiotomy ReservoirJOD · Traditional | Sterile Design, Inc. | 10/15/1984SE |
| K823260 | Interface Cardiotomy Blood Filter #51JOD · Traditional | Medical, Inc. | 11/24/1982SE |
| K823259 | Interface Cardiotomy Blood Filter #50JOD · Traditional | Medical, Inc. | 11/24/1982SE |
| K812243 | Interface Cardiotomy Blood Filter #51JOD · Traditional | Medical, Inc. | 08/25/1981SE |
| K781383 | Interface Cardiotomy Blood FilterJOD · Traditional | Medical, Inc. | 09/27/1978SE |
More from Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K893417 | Surgifresh Sub-Micron Mask No. 901008-000FXX · Traditional | 06/22/1989SE |
| K870932 | Surgifresh Surgical Smoke Removal · Traditional | 03/31/1987SE |
| K851575 | Dr. Bruno Lnage Mini Photometer · Traditional | 10/18/1985SE |
| K813587 | Disposable Thoracic CatheterGBS · Traditional | 01/12/1982SE |
| K810532 | Disposable StopcockDTZ · Traditional | 04/23/1981SE |
| K810515 | Disposable 2-STAGE CannulaDWF · Traditional | 04/23/1981SE |
| K810395 | Pre-Bypass FilterKRJ · Traditional | 03/05/1981SE |
| K802545 | Cardioplegic SetsDTR · Traditional | 01/16/1981SE |
| K802544 | Disposable Quick Release Perfusion AdapDTL · Traditional | 01/16/1981SE |
| K802543 | Ridgid Vena Cava CannulaeDWF · Traditional | 01/16/1981SE |
Questions and answers
When was Cardiotomy Filter cleared by the FDA?
Cardiotomy Filter (K830634) received a 510(k) decision of Substantially Equivalent on June 30, 1983, 121 days after the submission was received.
What is the product code of K830634?
The FDA product code is JOD – Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4270.