TUBING CONNECTORS EC-2XXX SERIES
FDA 510(k) clearance K833322 · decided 1983-12-16
Clearance details
- K-number
- K833322
- Device name
- TUBING CONNECTORS EC-2XXX SERIES
- Applicant
- Gish Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-09-26
- Decision date
- 1983-12-16
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- DTL
- Device class
- 2
- Regulation number
- 870.4290
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot recall (Z-0157-2013) | Sorin Group USA, Inc. | 2012-10-25 |
| Gish 3/8 x 1/2" Reducer Connector with Luer fitting, Item Numbers: EC2180S, Lot Numbers: 1 recall (Z-0158-2013) | Sorin Group USA, Inc. | 2012-10-25 |