Company Overview
Gish Biomedical, Inc. was a United States-based medical device manufacturer specializing in cardiopulmonary bypass and perfusion-related products. The company developed arterial line filters, oxygenators, and ancillary perfusion circuit components used in cardiac surgery and extracorporeal circulation procedures.
Gish Biomedical operated as an independent manufacturer and supplied products to hospitals and perfusionists in the United States and internationally. The company is no longer active as an independent entity.
Historical Status
Gish Biomedical, Inc. was subsequently acquired and integrated into another organization. Its product lines and operations were transitioned accordingly. This website does not represent the acquiring company and is not affiliated with any successor entity.
Regulatory and FDA Information
During its operation, Gish Biomedical, Inc. submitted multiple premarket notifications to the U.S. Food and Drug Administration under the 510(k) pathway. These regulatory records remain part of the FDA's public database and are preserved for historical and research reference.
The complete FDA 510(k) clearance history for Gish Biomedical, Inc., including device names, product codes, and clearance dates, is maintained by an independent regulatory database: View FDA 510(k) clearance history for Gish Biomedical .
Known FDA 510(k) Clearances
The following device categories received FDA 510(k) clearance under Gish Biomedical, Inc. between 1983 and 2009. Records are sourced from FDA public regulatory filings.
| K-Number | Device | Category | Year |
|---|---|---|---|
| K851003 | Arterial Filter AFS-XX | Filter, Blood, Cardiopulmonary Bypass | 1985 |
| K914791 | Gish Arterial Filter | Filter, Blood, Cardiopulmonary Bypass | 1993 |
| K961530 | Gish Reliance Oxygenator (HFO) | Oxygenator, Cardiopulmonary Bypass | 1996 |
| K023381 | Vision Hollow Fiber Oxygenator with Guardian Coating | Oxygenator, Cardiopulmonary Bypass | 2003 |
| K844229 | Venous Reservoir VRS-XXX Series | Reservoir, Blood, Cardiopulmonary Bypass | 1985 |
| K955046 | Soft Venous Reservoir | Reservoir, Blood, Cardiopulmonary Bypass | 1996 |
| K833662 | Cardioplegia System CCS-XXX Series | Heat-exchanger, Cardiopulmonary Bypass | 1983 |
| K020106 | Vision Blood Cardioplegia System | Heat-exchanger, Cardiopulmonary Bypass | 2002 |
| K832594 | Pre-Bypass Filter EC-PBF Series | Filter, Prebypass, Cardiopulmonary Bypass | 1983 |
| K874839 | Stat-Sat | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass | 1988 |
Source: U.S. Food and Drug Administration, 510(k) Premarket Notification public database. Full regulatory details, including all 75 cleared devices, are available at Gish Biomedical FDA 510(k) archive.
Disclaimer
This page is not affiliated with the original owners, shareholders, or management of Gish Biomedical, Inc., or with any successor or acquiring company. It is provided solely for historical and research reference purposes. No commercial activity is conducted through this domain. Information is provided without warranty of completeness or accuracy.