Atlas FDA

3T L. V. CONTROL VALVE

FDA 510(k) clearance K001245 · decided 2001-08-15

Clearance details

K-number
K001245
Device name
3T L. V. CONTROL VALVE
Applicant
3t Medical Systems, LLC
Decision
Substantially Equivalent
Date received
2000-04-18
Decision date
2001-08-15
Days to decision
484 days
Clearance type
Traditional
Product code
MJJ
Device class
2
Regulation number
870.4400
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Troy, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Cardiovascular Custom Procedure Kits, REV OA PERFUSION W/4:1 CARDIOPLEGIA Item Number 7299 recall (Z-3222-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, Rev O, REV 1, REV 1A, REV 2 X-COATED 8:1 FX PACK Ite recall (Z-3223-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, Rev OA FX 8:1 PACK Item Number :73315 Terumo Cardiov recall (Z-3224-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, Rev O X-Coated 8:1 CP No OXY Item Number: 73329 Teru recall (Z-3225-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV.0 REV.0A, REV.1 X-Coated 4:1 CP50 FX Pack Item N recall (Z-3226-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV..1 X-Coated Stand Alone Adult Pack Item Number: recall (Z-3227-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV.2, REV. 3 PUMP & TABLE PACK 1/4 Terumo Cardiovas recall (Z-3228-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV.3, REV. 5 X-COATED 8:1 CARDIOPLEGIA Item Number: recall (Z-3229-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV.OB PERFUSION W/8:1 CARDIOPLEGIA Item Number: 716 recall (Z-3230-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV.4, REV. 5 X-COATED NEONATAL PACK 3/16" Item Numb recall (Z-3231-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV.0, REV 1, REV 1A, REV. 2 XCoated 8:1 FX PACK Ite recall (Z-3232-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV.0 FX 8:1 PACK Item Number: 73329 Terumo Cardiova recall (Z-3233-2011)Terumo Cardiovascular Systems Corp2011-09-16
Adjustable Valve Item Number: 73631 Terumo Cardiovascular Systems, Ashland, MA 01721 The C recall (Z-3234-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 2 X-COATED 3/8 X 3/8 A-V LOOP Item Number: 7394 recall (Z-3235-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 1 X-COATED 3/8 X 1/2 A-V LOOP Item Number: 7395 recall (Z-3236-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 5 X-COATED FPS ADULT PACK Item Number: 73325 Te recall (Z-3237-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 5 STANDARD PACK Item Number: 71701 Terumo Cardi recall (Z-3238-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV :10. REV 13, REV17, REV 18 FX X-Coated Perfusion recall (Z-3239-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV :2. REV 2A, REV: 17, REV 18 X-COATED FX PACK Ite recall (Z-3240-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV :3. REV: 4, REV: 5, REV: 6, REV:7 X-Coated 8000 recall (Z-3241-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV : 2, REV: 4 FX, CP50,CENT Pack Item Number: 7338 recall (Z-3242-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV : 3 General Low Prime Item Number: 73563 Terumo recall (Z-3243-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 2, REV:2A, REV: 5, REV: 7 X-Coated FX PERFUSION recall (Z-3244-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 0, REV: 1 REV: 4, REV: 6A, REV: 6B. REV: 6C COA recall (Z-3245-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 1 REV: 1A COATED FX PK Item Number: 72985-02 Te recall (Z-3246-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 2A, REV: 2B X-COATED FX PK Item Number: 73191 T recall (Z-3247-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 1A, REV :1 X-COATED FX PK Item Number: 73191-01 recall (Z-3248-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 8 Comprensive X-COATED 8000 FX PK Item Number: recall (Z-3249-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 4 FX, CP50 CENT. PK Item Number: 73386 Terumo C recall (Z-3250-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 3, REV: 3A, REV:4 FX, CP50 CENT. PK Item Number recall (Z-3251-2011)Terumo Cardiovascular Systems Corp2011-09-16
Cardiovascular Custom Procedure Kits, REV: 0, REV: 2, REV:6 X-Coated FX Perfusion Pack Ite recall (Z-3252-2011)Terumo Cardiovascular Systems Corp2011-09-16
Adjustable Vent Valve, TruChoice Alliant Healthcare Products REFERENCE#213-030 QUANTITY: 2 recall (Z-3058-2011)Alliant Enterprises LLC2011-08-23
Adjustable Vent Valve, TruChoice Alliant Healthcare Products REFERENCE#213-030NS QUANTITY: recall (Z-3059-2011)Alliant Enterprises LLC2011-08-23
Non-Adjustable Vent Valve, TruChoice Alliant Healthcare Products, REFERENCE#213-035NS QUAN recall (Z-3060-2011)Alliant Enterprises LLC2011-08-23
Non-Adjustable Vent Valve, TruChoice Alliant Healthcare Products, REFERENCE#213-035 QUANTI recall (Z-3061-2011)Alliant Enterprises LLC2011-08-23
TruChoice Alliant Healthcare Products, REFERENCE# SSD-100EX, QUANTITY: 25, DESCRIPTION: TU recall (Z-3062-2011)Alliant Enterprises LLC2011-08-23