510(k) K833322 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
TUBING CONNECTORS EC-2XXX SERIES
| Applicant | Gish Biomedical, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Dec 16, 1983 |
| Received | Sep 26, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K833322
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert Label:050432000
/ 00803622123184 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert Label:050434000/ 00803622123207 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. 1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. 3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. 3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. 1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. 1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322 Terminated |
DTL | None listed |
| Nov 18, 2019 | LivaNova USA Inc. LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case Terminated |
DTL | None listed |
| Oct 25, 2012 | Sorin Group USA, Inc. Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 1215100026, 1217000138, Exp. Dates: 4/16/17, 5/31/15, 7/31/15.
Product Usage: The conne Terminated |
DTL | None listed |
| Oct 25, 2012 | Sorin Group USA, Inc. Gish 3/8 x 1/2" Reducer Connector with Luer fitting, Item Numbers: EC2180S, Lot Numbers: 1108900099, 1119900091, 1203700129, 1208600013, 1219200107, Exp. Dates: 3/31/14, 7/31/14, 2/28/15, 3/31/15, 7/3 Terminated |
DTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.