Atlas FDA

MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA

FDA 510(k) clearance K920902 · decided 1993-05-11

Clearance details

K-number
K920902
Device name
MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA
Applicant
3M Health Care, Sarns
Decision
Substantially Equivalent
Date received
1992-02-26
Decision date
1993-05-11
Days to decision
440 days
Clearance type
Traditional
Product code
DWF
Device class
2
Regulation number
870.4210
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Ann Arbor, MI, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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Recalls involving this device

RecordFirmDate
Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connec recall (Z-2096-2014)Terumo Cardiovascular Systems Corporation2014-07-23
Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connecto recall (Z-2100-2014)Terumo Cardiovascular Systems Corporation2014-07-23
Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with recall (Z-2102-2014)Terumo Cardiovascular Systems Corporation2014-07-23
Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 recall (Z-1218-2014)Terumo Cardiovascular Systems Corporation2014-03-19
Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 recall (Z-1219-2014)Terumo Cardiovascular Systems Corporation2014-03-19
Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38 c recall (Z-1220-2014)Terumo Cardiovascular Systems Corporation2014-03-19
Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 c recall (Z-1221-2014)Terumo Cardiovascular Systems Corporation2014-03-19
Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 c recall (Z-1222-2014)Terumo Cardiovascular Systems Corporation2014-03-19
Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare The Sarns Malleable Dual recall (Z-1223-2014)Terumo Cardiovascular Systems Corporation2014-03-19
Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" flare The Sarns Malleable Dual recall (Z-1224-2014)Terumo Cardiovascular Systems Corporation2014-03-19