Atlas FDA

CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)

FDA 510(k) clearance K963097 · decided 1996-10-18

Clearance details

K-number
K963097
Device name
CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)
Applicant
Bmw Medical, Inc.
Decision
Substantially Equivalent
Date received
1996-08-09
Decision date
1996-10-18
Days to decision
70 days
Clearance type
Traditional
Product code
LJS
Device class
2
Regulation number
880.5970
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Salt Lake City, UT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CK, Material Number M001PIC402CK0. recall (Z-1049-05)Boston Scientific Corporation2005-07-28
PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKIR, Material Number M001PIC402CKI recall (Z-1050-05)Boston Scientific Corporation2005-07-28
PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKMS, Material Number M001PIC402CKM recall (Z-1051-05)Boston Scientific Corporation2005-07-28
PICC Custom Kit GENESIS MEDICAL CENTER, 4.5F Dual Lumen , Catalog #60M120522. UPN M00160M1 recall (Z-1052-05)Boston Scientific Corporation2005-07-28