Atlas FDA

PALEY TRANSPARENT MANIFOLD

FDA 510(k) clearance K760843 · decided 1976-11-12

Clearance details

K-number
K760843
Device name
PALEY TRANSPARENT MANIFOLD
Applicant
Usci, Div. C.R. Bard, Inc.
Decision
Substantially Equivalent
Date received
1976-10-14
Decision date
1976-11-12
Days to decision
29 days
Clearance type
Traditional
Product code
DTL
Device class
2
Regulation number
870.4290
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS (P890048/S006)Usci, Div. C.R. Bard, Inc.1997-02-04
USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS (P890048/S005)Usci, Div. C.R. Bard, Inc.1996-11-26
USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS (P890048/S004)Usci, Div. C.R. Bard, Inc.1995-06-14
USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS (P890048/S003)Usci, Div. C.R. Bard, Inc.1995-05-17
USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM (P890048)Usci, Div. C.R. Bard, Inc.1991-04-17