Atlas FDA

MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1

FDA 510(k) clearance K052431 · decided 2005-11-29

Clearance details

K-number
K052431
Device name
MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1
Applicant
Medtronic Minimed
Decision
Substantially Equivalent
Date received
2005-09-06
Decision date
2005-11-29
Days to decision
84 days
Clearance type
Traditional
Product code
FPK
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Northridge, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING (K131517)Medrad, Inc. / Bayer Medical Care, Inc.2013-08-02
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LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 (K063239)Hospira, Inc.2006-12-11
EMPOWER TRANSFER SET, (CAT. NO. 7725) (K041178)E-Z-Em, Inc.2004-07-16
MEDRAD SWABBABLE VALVE TRANSFER SET (K031808)Medrad, Inc.2003-07-11
MEDRAD TRANSFER SET (K022431)Medrad, Inc.2002-09-05
POLYFIN EXTENSION SET, MODELS 126 AND 128 (K965208)Medtronic Minimed1997-02-26
SILCLEAR TUBING (MODIFICATION) (K953864)Degania Silicone , Ltd.1995-11-06
SYSMEX SF-3000 (K950508)Sysmex Corp.1995-11-03
EXTENSION SET/I.V. SET (K952243)Coast Medical, Inc.1995-07-26
60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP (K952663)Distronic Sterile Products, Inc.1995-07-14
RECONSTITUTION ACCESSOREIS (K950861)Organon, Inc.1995-05-26

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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