Home / 510(k) Clearances / K982839

510(k) K982839

CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 by Sims Deltec, Inc. — Product Code MEA

K982839 is an FDA 510(k) premarket notification submitted by Sims Deltec, Inc. for the device "CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300". The FDA issued a decision of Substantially Equivalent on November 2, 1998. The device falls under product code MEA (Pump, Infusion, Pca), a Class II device regulated under 21 CFR 880.5725. Sims Deltec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1998
Date Received
August 12, 1998
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 Sims Deltec, Inc.

  • K010426 — PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CA (March 8, 2001)
  • K000842 — CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM (June 8, 2000)
  • K000942 — CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 (April 27, 2000)
  • K994216 — PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM (January 27, 2000)
  • K992697 — PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM (November 18, 1999)
  • K992880 — P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM (October 19, 1999)
  • K991599 — CADD ADMINISTRATION SET (June 15, 1999)
  • K991301 — CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPH (June 9, 1999)
  • K991255 — CADD-TPN ADMINISTRATION SET, MODEL 21-7071 (June 9, 1999)
  • K990083 — CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECU (February 12, 1999)

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