Atlas FDA

LOW VOLUME EXTENSION SET

FDA 510(k) clearance K864395 · decided 1986-12-16

Clearance details

K-number
K864395
Device name
LOW VOLUME EXTENSION SET
Applicant
Panamedix, Inc.
Decision
Substantially Equivalent
Date received
1986-11-06
Decision date
1986-12-16
Days to decision
40 days
Clearance type
Traditional
Product code
FPK
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Costa Mesa, CA, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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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

Recalls involving this device

No recalls on record reference this clearance.