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510(k) K020728

MIETHKE SHUNT SYSTEM by Aesculap, Inc. — Product Code HCA

K020728 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "MIETHKE SHUNT SYSTEM". The FDA issued a decision of Substantially Equivalent on April 5, 2002. The device falls under product code HCA (Catheter, Ventricular), a Class II device regulated under 21 CFR 882.4100. Aesculap, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2002
Date Received
March 6, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ventricular
Device Class
Class II
Regulation Number
882.4100
Review Panel
NE
Submission Type

Other clearances by Aesculap, Inc.

  • K242762 — Aesculap Aicon® Series Container System (May 13, 2025)
  • K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (December 16, 2024)
  • K223596 — SQ.line KERRISON (June 29, 2023)
  • K214041 — Aesculap AICON Container (December 30, 2022)
  • K211572 — Aesculap Slim Clip Applier (December 13, 2021)
  • K203739 — ELAN 4 Electro Motor System (August 24, 2021)
  • K202391 — DIR 800 (January 21, 2021)
  • K203461 — Aesculap Caiman 12 Seal and Cut Technology System (December 18, 2020)
  • K202938 — Aesculap Caiman 5 Seal and Cut Technology System (October 30, 2020)
  • K202124 — Aesculap PAS-Port Proximal Anastomosis System (September 2, 2020)

Other clearances for product code HCA

  • K161731 — Cleveland Multiport Ventricular Catheter Set (March 27, 2017)
  • K123605 — SMARTFLOW CATHETER (August 16, 2013)
  • K031123 — CODMAN BACTISEAL BARIUM STRIPED CATHETERS (May 14, 2003)
  • K021481 — BRESAGEN CATHETER, MODEL CS-3000 (August 6, 2002)
  • K013005 — ACT 11 MP VENTRICULAR CATHETER (March 8, 2002)
  • K003322 — CODMAN BACTISEAL CATHETERS (October 1, 2001)
  • K992796 — ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 (October 25, 1999)
  • K983331 — MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 (December 16, 1998)
  • K834477 — DISPOS. SCOTT CANNULAS 16-1054 ETC. (March 19, 1984)

FDA data resources