Atlas FDA

CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS

FDA 510(k) clearance K982891 · decided 1998-09-30

Clearance details

K-number
K982891
Device name
CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
Applicant
California Medical Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1998-08-17
Decision date
1998-09-30
Days to decision
44 days
Clearance type
Traditional
Product code
DTS
Device class
2
Regulation number
870.4420
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fl recall (Z-0649-2013)California Medical Laboratories Inc2013-01-07
Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were so recall (Z-0650-2013)California Medical Laboratories Inc2013-01-07
Terumo Sarns cardiovascular disposable products, Weighted Flexible Sucker, sterile, Terumo recall (Z-2046-2009)Terumo Cardiovascular Systems Corporation2009-08-04
CalMed Pericardial Sump, with 1/8"/0.3175 cm Connector Single Use Only. Do Not Reuse. REF recall (Z-1175-2008)California Medical Laboratories Inc2008-06-11
CalMed Pericardial Sump, with 1/4"/0.635 cm Connector, Single Use Only. Do Not Reuse; REF recall (Z-1176-2008)California Medical Laboratories Inc2008-06-11
CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed Lab recall (Z-1177-2008)California Medical Laboratories Inc2008-06-11
Cardiovascular Procedure Kit, P/N: 70932-01, HCSG-St. Mary's Hospital, Richmond, VA , X-co recall (Z-1310-2008)Terumo Cardiovascular Systems Corp2008-03-28
Cardiovascular Procedure Kit, P/N 64789-01, Wisconsin Cardiovascular Services Pump and Tab recall (Z-1311-2008)Terumo Cardiovascular Systems Corp2008-03-28
Cardiovascular Procedure Kit, P/N 70295-02, St. Louis University Hospital Pump & Table Pac recall (Z-1312-2008)Terumo Cardiovascular Systems Corp2008-03-28
Cardiovascular Procedure Kit, P/N 70579-04, St. Louis University Hospital Pump & Table Pac recall (Z-1313-2008)Terumo Cardiovascular Systems Corp2008-03-28