Atlas FDA

TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)...

FDA 510(k) clearance K111372 · decided 2011-08-04

Clearance details

K-number
K111372
Device name
TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)...
Applicant
Covidien
Decision
Unknown
Date received
2011-05-16
Decision date
2011-08-04
Days to decision
80 days
Clearance type
Special
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
Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm recall (Z-2632-2023)Covidien LP2023-09-25
Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute a recall (Z-1316-2022)Covidien Llc2022-07-07
Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and recall (Z-1320-2022)Covidien Llc2022-07-07

PMA approvals by this applicant

RecordFirmDate
MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S006)Covidien1997-06-24
MODEL 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S005)Covidien1995-12-28
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S004)Covidien1995-06-14
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S003)Covidien1994-06-17
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S002)Covidien1994-03-28
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S001)Covidien1993-09-10
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034)Covidien1991-12-13