510(k) K993060
- Device
- GAS FILTER
- Applicant
- OLSON MEDICAL SALES, INC.
- 510(k) number
- K993060
- Product code
- JOD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-03-28
- Date received
- 1999-09-13
- Regulation
- 870.4270
- Classification name
- Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GARRY A COURTNEY
- Address
- 2101 Cottontail Ln. Somerset NJ US 08873 08873
FDA Registration Numbers#
- 9680841
- 9617601
- 2184009
- 3011554160
- 2650143
- 3005941719
- 3037389071
- 2029275
- 3014936217
Source Documents#
Other 510(k) Records For Product Code JOD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890504 | CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS | Gish Biomedical, Inc. | 1989-03-10 |
| K875095 | PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE | Pall Biomedical Products Co. | 1988-02-29 |
| K874405 | PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE | Pall Biomedical Products Co. | 1987-12-30 |
| K855067 | SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 | Cobe Laboratories, Inc. | 1986-02-26 |
| K841958 | CARDIO METRICS CARDIOTOMY RESERVOIR | Sterile Design, Inc. | 1984-10-15 |
| K830634 | CARDIOTOMY FILTER | Texas Medical Products, Inc. | 1983-06-30 |
| K823259 | INTERFACE CARDIOTOMY BLOOD FILTER #50 | Medical, Inc. | 1982-11-24 |
| K823260 | INTERFACE CARDIOTOMY BLOOD FILTER #51 | Medical, Inc. | 1982-11-24 |
| K812243 | INTERFACE CARDIOTOMY BLOOD FILTER #51 | Medical, Inc. | 1981-08-25 |
| K781383 | INTERFACE CARDIOTOMY BLOOD FILTER | Medical, Inc. | 1978-09-27 |
| K780653 | EXTRACORPEAL CARDIOTOMY BLOOD FILTER | Cobe Laboratories, Inc. | 1978-06-14 |
Legacy Summary#
summary
FDA Review#
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