Atlas FDA

TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS

FDA 510(k) clearance K002902 · decided 2001-04-09

Clearance details

K-number
K002902
Device name
TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS
Applicant
The Kendall Company
Decision
Substantially Equivalent
Date received
2000-09-18
Decision date
2001-04-09
Days to decision
203 days
Clearance type
Traditional
Product code
MSD
Device class
2
Regulation number
876.5540
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Mansfield, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 19 cm Arterial Cuff/22cm Ve recall (Z-0742-03)Tyco Healthcare/Kendall2003-04-18
Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 23 cm Arterial Cuff/26cm Ve recall (Z-0743-03)Tyco Healthcare/Kendall2003-04-18
Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 28 cm Arterial Cuff/31 cm V recall (Z-0744-03)Tyco Healthcare/Kendall2003-04-18
Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 23 cm Arterial Cuff/26cm recall (Z-0746-03)Tyco Healthcare/Kendall2003-04-18
Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 28 cm Arterial Cuff/31cm recall (Z-0747-03)Tyco Healthcare/Kendall2003-04-18