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510(k) K920104

IDENTI LOOPS DEGANIA SILICONE by Puritas Health Care, Inc. — Product Code DSS

K920104 is an FDA 510(k) premarket notification submitted by Puritas Health Care, Inc. for the device "IDENTI LOOPS DEGANIA SILICONE". The FDA issued a decision of Substantially Equivalent on April 20, 1992. The device falls under product code DSS (Clip, Vascular), a Class II device regulated under 21 CFR 870.3250. Puritas Health Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1992
Date Received
January 9, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Vascular
Device Class
Class II
Regulation Number
870.3250
Review Panel
CV
Submission Type

Other clearances by Puritas Health Care, Inc.

  • K942339 — SKIN NEUVEAU SCAR TREATMENT (November 28, 1994)
  • K941197 — SILK*SKIN SCAR TREATMENT (August 11, 1994)
  • K935600 — TRACHEAL SUCTION CATHETER (May 10, 1994)
  • K935531 — OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP (May 5, 1994)
  • K940074 — Y-TYPE BLOOD ADMINISTRATION SET (April 21, 1994)
  • K940054 — MEASURED VOLUME SOLUTION ADMINISTRATION SET (April 15, 1994)
  • K940055 — MULTISET (April 15, 1994)
  • K935583 — SUCTION SET, TRACHAEL (April 11, 1994)
  • K940070 — STOPCOCK INTRAVENOUS THERAPY (April 4, 1994)
  • K940056 — WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM (April 4, 1994)

Other clearances for product code DSS

  • K983744 — MCAS (MODULAR CLIP APPLIER SYSTEM) (January 21, 1999)
  • K961333 — HEARTPORT MULTIFIRE CLIP APPLIER (November 15, 1996)
  • K920676 — RMI SOFCLAMP (April 15, 1992)
  • K914523 — CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL (January 10, 1992)
  • K901303 — HORIZON SURGICAL LIGATING AND MARKING CLIP (June 5, 1990)
  • K883909 — SURGICAL SPRING CLIPS (December 27, 1988)
  • K771021 — AUTO-CLIP (June 14, 1977)

FDA data resources