510(k) K982891 ยท DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
| Applicant | California Medical Laboratories, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Sep 30, 1998 |
| Received | Aug 17, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982891
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2013 | California Medical Laboratories Inc Sterile Rigid Tip Suction Wand
The Suction Wands are indicated for use to remove excess fluid from the surgical field. Terminated |
DTS | None listed |
| Jan 7, 2013 | California Medical Laboratories Inc Rigid Tip Suction Wand
Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name.
The Suction Wands are indicated Terminated |
DTS | None listed |
| Aug 4, 2009 | Terumo Cardiovascular Systems Corporation Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; Catalog No. 804113. Terminated |
DTS | None listed |
| Jun 11, 2008 | California Medical Laboratories Inc CalMed Pericardial Sump, with 1/8"/0.3175 cm Connector Single Use Only. Do Not Reuse. REF SU-20601; CalMed Laboratories, Costa Mesa, CA 92626 Terminated |
DTS | None listed |
| Jun 11, 2008 | California Medical Laboratories Inc CalMed Pericardial Sump, with 1/4"/0.635 cm Connector, Single Use Only. Do Not Reuse; REF SU-20602; CalMed Laboratories, Costa Mesa, CA 92626 Terminated |
DTS | None listed |
| Jun 11, 2008 | California Medical Laboratories Inc CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed Laboratories, Costa Mesa, CA 92626 Terminated |
DTS | None listed |
| Mar 28, 2008 | Terumo Cardiovascular Systems Corp Cardiovascular Procedure Kit, P/N: 70932-01, HCSG-St. Mary's Hospital, Richmond, VA , X-coated Pump and Table Pack, Terumo Cardiovascular, Ashland, MA (the X-coated pump and table pack contains a weig Terminated |
OEZ | None listed |
| Mar 28, 2008 | Terumo Cardiovascular Systems Corp Cardiovascular Procedure Kit, P/N 64789-01, Wisconsin Cardiovascular Services Pump and Table Pack, Terumo Cardiovascular, Ashland, MA. (the Pump & table pack contains a weighted flexible sucker, Catal Terminated |
OEZ | None listed |
| Mar 28, 2008 | Terumo Cardiovascular Systems Corp Cardiovascular Procedure Kit, P/N 70295-02, St. Louis University Hospital Pump & Table Pack, Terumo Cardiovascular, Ashland, MA. ( Pump & table pack contains a weighted flexible sucker, Catalog No. Terminated |
OEZ | None listed |
| Mar 28, 2008 | Terumo Cardiovascular Systems Corp Cardiovascular Procedure Kit, P/N 70579-04, St. Louis University Hospital Pump & Table Pack, Terumo Cardiovascular, Ashland, MA. (the Pump & Table pack contains a weighted flexible sucker, Catalog No. Terminated |
OEZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.