510(k) K001245 ยท MJJ Cpb Check Valve, Retrograde Flow, In-Line
3T L. V. CONTROL VALVE
| Applicant | 3t Medical Systems, LLC, Troy MI, US |
| Decision | Substantially Equivalent, Aug 15, 2001 |
| Received | Apr 18, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001245
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV OA
PERFUSION W/4:1 CARDIOPLEGIA
Item Number 72990
Terumo Cardiovascular Systems Corp.
The Cardiovascular Procedure Kits are indicated for use only in the ext Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, Rev O, REV 1, REV 1A, REV 2
X-COATED 8:1 FX PACK
Item Number 73192
Terumo Cardiovascular Systems Corp.
The Cardiovascular Procedure Kits are indicated for use o Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, Rev OA
FX 8:1 PACK
Item Number :73315
Terumo Cardiovascular Systems Corp.
The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal cir Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, Rev O
X-Coated 8:1 CP No OXY
Item Number: 73329
Terumo Cardiovascular Systems Corp.
The Cardiovascular Procedure Kits are indicated for use only in the extracorp Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV.0 REV.0A, REV.1
X-Coated 4:1 CP50 FX Pack
Item Number: 73381
Terumo Cardiovascular Systems Corp.
The Cardiovascular Procedure Kits are indicated for use onl Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV..1
X-Coated Stand Alone Adult Pack
Item Number: 73413
Terumo Cardiovascular Systems Corp.
The Cardiovascular Procedure Kits are indicated for use only in th Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV.2, REV. 3
PUMP & TABLE PACK 1/4
Terumo Cardiovascular Systems, Ashland, MA 0172
Item Number: 71038-05
Terumo Cardiovascular Systems Corp.
The Cardiovascular Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV.3, REV. 5
X-COATED 8:1 CARDIOPLEGIA
Item Number: 71071-02
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indicated fo Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV.OB
PERFUSION W/8:1 CARDIOPLEGIA
Item Number: 71653-04
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indicated for us Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV.4, REV. 5
X-COATED NEONATAL PACK 3/16"
Item Number: 72651-02
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indicated Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV.0, REV 1, REV 1A, REV. 2
XCoated 8:1 FX PACK
Item Number: 73192
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indic Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV.0
FX 8:1 PACK
Item Number: 73329
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indicated for use only in the extraco Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Adjustable Valve
Item Number: 73631
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardi Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV: 2
X-COATED 3/8 X 3/8 A-V LOOP
Item Number: 73946
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indicated for use o Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV: 1
X-COATED 3/8 X 1/2 A-V LOOP
Item Number: 73954
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indicated for use o Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV: 5
X-COATED FPS ADULT PACK
Item Number: 73325
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indicated for use only i Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV: 5
STANDARD PACK
Item Number: 71701
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indicated for use only in the ext Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV :10. REV 13, REV17, REV 18
FX X-Coated Perfusion Pack
Item Number: 72941
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV :2. REV 2A, REV: 17, REV 18
X-COATED FX PACK
Item Number: 73191
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indica Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV :3. REV: 4, REV: 5, REV: 6, REV:7
X-Coated 8000 FX PACK
Item Number: 73252
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure K Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV : 2, REV: 4
FX, CP50,CENT Pack
Item Number: 73386
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indicated for use o Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV : 3
General Low Prime
Item Number: 73563
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indicated for use only in the Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV: 2, REV:2A, REV: 5, REV: 7
X-Coated FX PERFUSION PK
Item Number: 72941-01
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV: 0, REV: 1
REV: 4, REV: 6A, REV: 6B. REV: 6C
COATED FX PK
Item Number: 72985-01
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedur Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV: 1
REV: 1A
COATED FX PK
Item Number: 72985-02
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indicated for use only Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV: 2A, REV: 2B
X-COATED FX PK
Item Number: 73191
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indicated for use only Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV: 1A, REV :1
X-COATED FX PK
Item Number: 73191-01
The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiop Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV: 8
Comprensive X-COATED 8000 FX PK
Item Number: 73252
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indicated for Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV: 4
FX, CP50 CENT. PK
Item Number: 73386
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indicated for use only in the Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV: 3, REV: 3A, REV:4
FX, CP50 CENT. PK
Item Number: 73386-01
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indicated Terminated |
MJJ | None listed |
| Sep 16, 2011 | Terumo Cardiovascular Systems Corp Cardiovascular Custom Procedure Kits, REV: 0, REV: 2, REV:6
X-Coated FX Perfusion Pack
Item Number: 73785
Terumo Cardiovascular Systems, Ashland, MA 01721
The Cardiovascular Procedure Kits are indic Terminated |
MJJ | None listed |
| Aug 23, 2011 | Alliant Enterprises LLC Adjustable Vent Valve, TruChoice Alliant Healthcare Products REFERENCE#213-030 QUANTITY: 25 DESCRIPTION: ADJUSTABLE VENT VALVE, STERILE
The TruChoice Vacuum Control One-Way Vent Valve is indicated fo Terminated |
MJJ | None listed |
| Aug 23, 2011 | Alliant Enterprises LLC Adjustable Vent Valve, TruChoice Alliant Healthcare Products REFERENCE#213-030NS QUANTITY: 100 DESCRIPTION: ADJUSTABLE VENT VALVE, NON-STERILE; and 3T Medical Systems Catalog# 030NS Adjustable One Way Terminated |
MJJ | None listed |
| Aug 23, 2011 | Alliant Enterprises LLC Non-Adjustable Vent Valve, TruChoice Alliant Healthcare Products, REFERENCE#213-035NS QUANTITY: 100, DESCRIPTION: NONADJUSTABLE VENT VALVE, NON-STERILE; AND and 3-T Medical Systems, Catalog #035NS, No Terminated |
MJJ | None listed |
| Aug 23, 2011 | Alliant Enterprises LLC Non-Adjustable Vent Valve, TruChoice Alliant Healthcare Products, REFERENCE#213-035 QUANTITY: 25, DESCRIPTION: NONADJUSTABLE VENT VALVE, STERILE
The TrueChoice Vacuum Control One-Way Vent Valve is in Terminated |
MJJ | None listed |
| Aug 23, 2011 | Alliant Enterprises LLC TruChoice Alliant Healthcare Products, REFERENCE# SSD-100EX, QUANTITY: 25, DESCRIPTION: TUBING W/ ONE WAY VALVE, STERILE
The TrueChoice Vacuum Control One-Way Vent Valve is indicated for use during c Terminated |
MJJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.