Atlas FDA

VAXCEL PLUS CHRONIC DIALYSIS CATHETER

FDA 510(k) clearance K032712 · decided 2003-10-02

Clearance details

K-number
K032712
Device name
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
Applicant
Boston Scientific Corp
Decision
Substantially Equivalent
Date received
2003-09-02
Decision date
2003-10-02
Days to decision
30 days
Clearance type
Special
Product code
MSD
Device class
2
Regulation number
876.5540
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Natick,, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/19/Metal Catalog Number : 45-540 recall (Z-1487-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/19/Plastic Catalog Number : 45-54 recall (Z-1488-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/19/Plastic Catalog Number : 45-543 recall (Z-1490-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/23/Plastic Catalog Number : 45-54 recall (Z-1492-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/23/Metal Catalog Number : 45-546 recall (Z-1493-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/23/Plastic Catalog Number : 45-547 recall (Z-1494-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/28/Metal Catalog Number : 45-548 recall (Z-1495-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/28/Plastic Catalog Number : 45-54 recall (Z-1496-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/28/Metal Catalog Number : 45-550 recall (Z-1497-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/28/Plastic Catalog Number : 45-551 recall (Z-1498-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/50/Plastic Catalog Number: 45-557 recall (Z-1504-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/50/Metal Catalog Number: 45-558 recall (Z-1505-05)Boston Scientific Corporation2005-09-02
Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/50/Plastic Catalog Number: 45-559 recall (Z-1506-05)Boston Scientific Corporation2005-09-02

PMA approvals by this applicant

RecordFirmDate
ALTRUA™ 2 (Models S701, S702, S722) ESSENTIO™ (Models L100, L101, L121) PROPONENT™ (Models L200, L201, L221) ACCOLADE™ ( (N970003/S304)Boston Scientific Corp2025-12-19
WaveWriter Alpha Spinal Cord Stimulator (SCS) Mixed Systems, M8 Adaptor (P030017/S374)Boston Scientific Corp2025-12-18
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S082)Boston Scientific Corp2025-12-18
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S090)Boston Scientific Corp2025-12-17
ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321) (N970003/S305)Boston Scientific Corp2025-12-17
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S390)Boston Scientific Corp2025-12-17
WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S079)Boston Scientific Corp2025-12-15
WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S078)Boston Scientific Corp2025-12-15