Atlas FDA

LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526

FDA 510(k) clearance K063239 · decided 2006-12-11

Clearance details

K-number
K063239
Device name
LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526
Applicant
Hospira, Inc.
Decision
Substantially Equivalent
Date received
2006-10-26
Decision date
2006-12-11
Days to decision
46 days
Clearance type
Traditional
Product code
FPK
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Lake Forest, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Hospira

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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
DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES (K063114)Coeur, Inc.2007-02-09
MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 (K052431)Medtronic Minimed2005-11-29
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

RecordFirmDate
Lifeshield, latex-free 100mL Burette Set, convertible pin, 77 inch with 2 pre-pierced inje recall (Z-1327-2010)Hospira Inc.2010-04-15
Lifeshield, latex-free, 150 mL Burette Set, convertible pin, 77 inch with capped port and recall (Z-1330-2010)Hospira Inc.2010-04-15
Lifeshield, latex-free, 150 mL Burette Set, convertible pin, 77.5 inch with 2 pre-pierced recall (Z-1331-2010)Hospira Inc.2010-04-15
Lifeshield, latex-free, 150 mL Burette Set, convertible pin, 77 inch with 2 CLAVE ports SO recall (Z-1333-2010)Hospira Inc.2010-04-15
Lifeshield, CVP Manometer, latex-free, Y-type primary IV set, nonvented, 86.5 inch with pr recall (Z-1336-2010)Hospira Inc.2010-04-15
Lifeshield, latex-free, Secondary I.V. Set, convertible pin, 32 inch, piggyback with drop- recall (Z-1390-2010)Hospira Inc.2010-04-15
Lifeshield, latex-free Secondary I.V. Set, convertible pin, 34 inch, piggyback with OPTION recall (Z-1391-2010)Hospira Inc.2010-04-15

PMA approvals by this applicant

RecordFirmDate
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S008)Hospira, Inc.1999-01-29
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S007)Hospira, Inc.1996-09-05
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S006)Hospira, Inc.1996-01-04
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S003)Hospira, Inc.1995-12-15
DEXTRAN HM 32 (P880028/S002)Hospira, Inc.1990-11-15
DEXTRAN HM 32 (P880028/S001)Hospira, Inc.1989-12-29
DEXTRAN HM 32% (P880028)Hospira, Inc.1989-05-30