Atlas FDA

VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238

FDA 510(k) clearance K031844 · decided 2003-07-15

Clearance details

K-number
K031844
Device name
VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238
Applicant
Boston Scientific Corp
Decision
Substantially Equivalent
Date received
2003-06-16
Decision date
2003-07-15
Days to decision
29 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
Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. CATALOG NO. 45-236, Ref. recall (Z-0781-05)Boston Scientific Corporation2005-04-28
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Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Low Profile PS port, Implantable recall (Z-0733-04)Boston Scientific Corporation2004-07-20

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