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510(k) K931629

CARAPACE ANGIOGRAPHY TRAYS by Carapace, Inc. — Product Code DQO

K931629 is an FDA 510(k) premarket notification submitted by Carapace, Inc. for the device "CARAPACE ANGIOGRAPHY TRAYS". The FDA issued a decision of Substantially Equivalent on December 6, 1993. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Carapace, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1993
Date Received
April 2, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Other clearances by Carapace, Inc.

  • K931722 — CARAPACE LABOR AND DELIVERY SETS (March 23, 1994)
  • K931822 — CARAPACE PELVIC EXAM TRAYS (March 7, 1994)
  • K931729 — I.V. START KIT (February 22, 1994)
  • K931669 — CARAPACE DEBRIDEMENT KITS (February 7, 1994)
  • K931820 — CARAPACE STILLWATER BOWL SET (February 7, 1994)
  • K931760 — CARAPACE PACKING GAUZE TRAYS (February 4, 1994)
  • K932653 — SWISSTEK 2000(TM) CAST REMOVAL SYSTEM (January 28, 1994)
  • K931819 — CARAPACE SUTURE REMOVAL TRAYS (January 26, 1994)
  • K931758 — CARAPACE WOUND DRESSING KITS & LACERATION TRAYS (January 26, 1994)
  • K931759 — CARAPACE STERILE GAUZE TRAYS (January 25, 1994)

Other clearances for product code DQO

  • K261455 — Arterial Pressure Monitoring Set/Tray (June 26, 2026)
  • K252702 — Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, (May 28, 2026)
  • K254278 — Arterial Pressure Monitoring Set/Tray (March 25, 2026)
  • K250751 — DualView Catheter (July 17, 2025)
  • K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (January 31, 2025)
  • K242420 — pNOVUS 21 Microcatheter (November 12, 2024)
  • K233268 — Impress Angiographic Catheter (May 22, 2024)
  • K233975 — Zoom 6F Insert Catheters (April 2, 2024)
  • K232536 — Soldier Microcatheter (February 23, 2024)
  • K232573 — INFINITI™ Ambi Angiographic Catheter (November 21, 2023)

FDA data resources