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510(k) K911791

CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP by Pharmacia Deltec, Inc. — Product Code MEA

K911791 is an FDA 510(k) premarket notification submitted by Pharmacia Deltec, Inc. for the device "CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on June 11, 1991. The device falls under product code MEA (Pump, Infusion, Pca), a Class II device regulated under 21 CFR 880.5725. Pharmacia Deltec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1991
Date Received
April 22, 1991
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 Pharmacia Deltec, Inc.

  • K943310 — MODEL 6100 AMBULATORY INFUSION SYSTEM (February 21, 1995)
  • K942046 — PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE (October 4, 1994)
  • K942161 — LOCKBOX (August 2, 1994)
  • K942024 — PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM (July 26, 1994)
  • K941445 — EXTENSION SET WITH ANTI-SIPHON VALVE (June 29, 1994)
  • K931073 — CATH-FINDER (May 5, 1994)
  • K932433 — PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE (May 2, 1994)
  • K932211 — PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS (May 2, 1994)
  • K932198 — PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH (May 2, 1994)
  • K932464 — PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH. (May 2, 1994)

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