Atlas FDA

PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)

FDA 510(k) clearance K945461 · decided 1995-02-03

Clearance details

K-number
K945461
Device name
PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)
Applicant
Medtronics Interventional Vascular
Decision
Substantially Equivalent
Date received
1994-11-07
Decision date
1995-02-03
Days to decision
88 days
Clearance type
Traditional
Product code
DTL
Device class
2
Regulation number
870.4290
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Danvers, MA, 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
THE MEDTRONIC ACHIEVER CORONARY BALLON DILATION CATHETER (P870036/S044)Medtronics Interventional Vascular1998-11-17
MEDTRONIC WIKTOR RIVAL CORONARY STENT SYSTEM (P960010/S001)Medtronics Interventional Vascular1998-05-21
MEDTRONIC(R)MILLENIA TM 15 CORONARY BALLOON DILATATION CATHETER (P870036/S043)Medtronics Interventional Vascular1997-08-12
MEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL (P870036/S042)Medtronics Interventional Vascular1997-07-28
MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM (P960010)Medtronics Interventional Vascular1997-06-27
MEDTRONIC(R) EVERGREEN(TM) CORONARY BALLOON DILATATION CATHETERS (P870036/S041)Medtronics Interventional Vascular1997-03-07
MEDTRONIC(R) FALCON(R) CORONARY BALLOON DILATATION CATHETERS (P870036/S040)Medtronics Interventional Vascular1996-10-25
MEDTRONIC(R) MILLENIA (TM) FAMILY OF CORONARY BALLOON DILATATION CATHETERS (P870036/S038)Medtronics Interventional Vascular1996-09-25