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FDA Import Refusal 799-6065574-9/2/5 — Datascope Corp.

Datascope Corp. — FEI 1000222374

The FDA refused shipment 799-6065574-9/2/5 from Datascope Corp. (United States) on July 27, 2016. The refused product falls under Devices — SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL. Cited charges: 118,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
July 27, 2016
Country
United States
Product Category
Devices
Product Code
74DSP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Charges
118,508

Recent inspections

  • 1055241 (OAI Mon Jun 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 656265 (NAI Wed Mar 24 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-3629447-7/11/1 (Wed Nov 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-6065574-9/1/1 (Wed Jul 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-6065574-9/2/1 (Wed Jul 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-6065574-9/2/2 (Wed Jul 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-6065574-9/2/3 (Wed Jul 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources