Tyco Healthcare/Kendall
Mansfield, MA, US
Tyco Healthcare/Kendall appears in FDA device records in Mansfield, MA. FDA records list 4 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 6 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Tyco Healthcare/Kendall between 2004 and 2006. The busiest year on record is 2004, with 2. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K060339 | KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY | NGT | Substantially Equivalent | |
| K051805 | KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE | JOW | Substantially Equivalent | |
| K040511 | SCD EXPRESS PORTABLE COMPRESSION SYSTEM | JOW | Substantially Equivalent | |
| K040196 | KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS | LZH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0747-03 | Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 28 cm Arterial Cuff/31cm Venous Cuff Code #: 8888-228310 | Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter | Terminated | ||
| Z-0746-03 | Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 23 cm Arterial Cuff/26cm Venous Cuff Code #: 8888-223260 | Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter | Terminated | ||
| Z-0745-03 | Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 19 cm Arterial Cuff/22cm Venous Cuff Code #: 8888-219220 | Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter | Terminated | ||
| Z-0744-03 | Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 28 cm Arterial Cuff/31 cm Venous Cuff Code #: 8888-228316 | Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter | Terminated | ||
| Z-0743-03 | Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 23 cm Arterial Cuff/26cm Venous Cuff Code #: 8888-223266 | Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter | Terminated | ||
| Z-0742-03 | Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 19 cm Arterial Cuff/22cm Venous Cuff Code #: 8888-219226 | Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain