Atlas FDA

VAXCEL WITH PASV PORT

FDA 510(k) clearance K030083 · decided 2003-01-28

Clearance details

K-number
K030083
Device name
VAXCEL WITH PASV PORT
Applicant
Boston Scientific Corp
Decision
Substantially Equivalent
Date received
2003-01-09
Decision date
2003-01-28
Days to decision
19 days
Clearance type
Special
Product code
LJT
Device class
2
Regulation number
880.5965
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Glens Falls, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve a recall (Z-1874-2010)Navilyst Medical, Inc2010-07-01
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port With PASV Valve a recall (Z-1875-2010)Navilyst Medical, Inc2010-07-01
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve a recall (Z-1876-2010)Navilyst Medical, Inc2010-07-01
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV Val recall (Z-1877-2010)Navilyst Medical, Inc2010-07-01
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV Val recall (Z-1878-2010)Navilyst Medical, Inc2010-07-01
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Plastic Standard Port with PASV Valv recall (Z-1879-2010)Navilyst Medical, Inc2010-07-01
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM), Plastic Standard Port with PASV Val recall (Z-1880-2010)Navilyst Medical, Inc2010-07-01
Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Poly recall (Z-0630-2007)Boston Scientific Corp2007-03-15
Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Sili recall (Z-0631-2007)Boston Scientific Corp2007-03-15
Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Mini/T/PU/8/1.6/ recall (Z-1473-05)Boston Scientific Corporation2005-09-02
Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Mini/T/PU/8/1.6/ recall (Z-1474-05)Boston Scientific Corporation2005-09-02
Vaxcel Chest Ports - Mini/T/PU/6/1.1/1.9/63 Catalog Number : 45-303 recall (Z-1475-05)Boston Scientific Corporation2005-09-02
Vaxcel Chest Ports - Mini/T/S/8/1.5/2.6/63 Catalog Number : 45-310 recall (Z-1477-05)Boston Scientific Corporation2005-09-02
Vaxcel Chest Ports - Standard/T/PU/9/1.8/2.8/63 Catalog Number : 45-315 recall (Z-1478-05)Boston Scientific Corporation2005-09-02
Vaxcel Chest Ports - Standard/PS/S/8/1.5/2.6/63 Catalog Number : 45-340 recall (Z-1480-05)Boston Scientific Corporation2005-09-02
Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/T/PU/8/ recall (Z-1482-05)Boston Scientific Corporation2005-09-02
Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/T/S/8/1 recall (Z-1483-05)Boston Scientific Corporation2005-09-02
Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/PS/S/8/ recall (Z-1485-05)Boston Scientific Corporation2005-09-02
Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Mini Titanium port, Implantable P recall (Z-0731-04)Boston Scientific Corporation2004-07-20
Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD Titanium Port, Implantable Po recall (Z-0732-04)Boston Scientific Corporation2004-07-20
Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, STD PS port, Implantable Port Sys recall (Z-0734-04)Boston Scientific Corporation2004-07-20

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