Home / 510(k) Clearances / K921295

510(k) K921295

INTRAVENOUS CATHETERS MODIFICATIONS by Critikon Company, LLC — Product Code FGO

K921295 is an FDA 510(k) premarket notification submitted by Critikon Company, LLC for the device "INTRAVENOUS CATHETERS MODIFICATIONS". The FDA issued a decision of Substantially Equivalent on May 17, 1993. The device falls under product code FGO (Dislodger, Stone, Flexible), a Class II device regulated under 21 CFR 876.4680. Critikon Company, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1993
Date Received
March 12, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Flexible
Device Class
Class II
Regulation Number
876.4680
Review Panel
GU
Submission Type

Other clearances by Critikon Company, LLC

  • K002248 — DINAMAP PRO 1000 MONITOR, MODEL 1000 (September 21, 2000)
  • K000500 — DINAMAP ADVANCED NIBP MODULE (May 26, 2000)
  • K992638 — DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 (February 24, 2000)
  • K982342 — DINAMAP MPS SELECT PORTABLE MONITOR (August 14, 1998)
  • K943709 — DINAMAP PLUS VITAL SIGNS MONOITOR (June 16, 1995)
  • K942700 — DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340 (March 1, 1995)
  • K933404 — CRITIKON CENTRAL STATIN MONITOR (February 9, 1994)
  • K933050 — CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH (December 14, 1993)
  • K915697 — CRITIKON VITAL SIGNS MODULE (July 1, 1993)
  • K912188 — DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700 (December 4, 1991)

Other clearances for product code FGO

  • K001563 — SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET (November 22, 2000)
  • K970121 — STONE DISLODGER, BASKET (April 2, 1997)
  • K963750 — RETRIEVAL SNARE (November 22, 1996)
  • K962676 — DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE (October 4, 1996)
  • K951309 — STONE DISLODGER, BASKET (May 17, 1995)
  • K933261 — GRASPING FORCEPS (January 11, 1994)
  • K934598 — GRASPING FORCEPS OR RETRIEVAL FORCEPS (January 7, 1994)
  • K922542 — GRASPING FORCEPS (August 19, 1992)
  • K914110 — GRASPING FORCEPS (February 28, 1992)
  • K914111 — METAL URETERAL BASKET STONE DISLODGER, HELICAL (February 28, 1992)

FDA data resources