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510(k) K013822

MICROJET CRONO PCA by Cane S.R.L. — Product Code MEA

K013822 is an FDA 510(k) premarket notification submitted by Cane S.R.L. for the device "MICROJET CRONO PCA". The FDA issued a decision of Substantially Equivalent on May 8, 2002. The device falls under product code MEA (Pump, Infusion, Pca), a Class II device regulated under 21 CFR 880.5725. Cane S.R.L. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2002
Date Received
November 16, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Pca
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Cane S.R.L.

  • K091042 — CRONO S-PID 50 (May 12, 2009)
  • K052218 — CRONO FIVE AND CRONO PCA 50 (November 23, 2005)
  • K052219 — CRONO GO. (September 13, 2005)
  • K052217 — CRONO SUPER PID (September 13, 2005)
  • K042085 — CRONO F (September 17, 2004)
  • K041414 — CRONO AND CRONO, MODEL 30 (July 8, 2004)
  • K013840 — MICROJET CRONO PAR AND CRONO APO-GO (May 14, 2002)
  • K013234 — MICROJET CRONO (April 26, 2002)
  • K013807 — MICROJET QUARK, MODEL U100 OR U40 (December 12, 2001)

Other clearances for product code MEA

  • K162165 — ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Inte (August 29, 2017)
  • K170982 — CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis I (August 24, 2017)
  • K143612 — LifeCare PCA Infusion System (April 8, 2016)
  • K130394 — CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 (December 9, 2013)
  • K092313 — PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM (November 4, 2009)
  • K072144 — CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE (March 7, 2008)
  • K051253 — MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR (July 15, 2005)
  • K043299 — MEDLEY PCA MODULE, MODEL 8120 (December 10, 2004)
  • K043256 — HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTE (December 6, 2004)
  • K042800 — LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (October 18, 2004)

FDA data resources