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510(k) K811851

S-610 SHUNT ADAPTOR SET by Dravon Medical, Inc. — Product Code KNR

K811851 is an FDA 510(k) premarket notification submitted by Dravon Medical, Inc. for the device "S-610 SHUNT ADAPTOR SET". The FDA issued a decision of Substantially Equivalent on August 31, 1981. The device falls under product code KNR (Adapter, A-V Shunt Or Fistula), a Class II device regulated under 21 CFR 876.5540. Dravon Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1981
Date Received
July 1, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adapter, A-V Shunt Or Fistula
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by Dravon Medical, Inc.

  • K873455 — S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS (September 14, 1987)
  • K860770 — AM-100 I/A AMPAC (April 21, 1986)
  • K832739 — STEDIFLO INFUSION SET (December 22, 1983)
  • K831842 — DRAVON T CLAMP (September 26, 1983)
  • K812771 — PERITONEAL DIALYSIS DRAINAGE (October 19, 1981)
  • K812772 — PERITONEAL DIALYSIS CYCLER SET (8UNIT) (October 19, 1981)
  • K800435 — HEMOSTATIC/TUBE OCCLUDING FORCEPS (March 12, 1980)
  • K782058 — CATHETER, BETA-CAP-PERITONEAL (February 27, 1979)
  • K782057 — CATHETER, RADIOPAQUE TENCKHOFF (February 27, 1979)
  • K781755 — DAP-PAK (February 15, 1979)

FDA data resources