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Reprocessed Atherectomy Catheter

FDA product code QTF · Class 2 · Cardiovascular

18
Registered devices
0
Adverse events
8
Recalls
1
510(k) clearances

Devices with this code

NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter — NORTH EAST SCIENTIFIC INCNES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter — NORTH EAST SCIENTIFIC INCNES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter — NORTH EAST SCIENTIFIC INCNES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter — NORTH EAST SCIENTIFIC INCNES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter — NORTH EAST SCIENTIFIC INCNES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter — NORTH EAST SCIENTIFIC INCNES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter — NORTH EAST SCIENTIFIC INCNES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter — NORTH EAST SCIENTIFIC INCNES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter — NORTH EAST SCIENTIFIC INCNES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter — NORTH EAST SCIENTIFIC INCNES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter — NORTH EAST SCIENTIFIC INCNES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter — NORTH EAST SCIENTIFIC INCNES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter — NORTH EAST SCIENTIFIC INCNES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter — NORTH EAST SCIENTIFIC INCNES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter — NORTH EAST SCIENTIFIC INCNES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter — NORTH EAST SCIENTIFIC INCNES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter — NORTH EAST SCIENTIFIC INCNES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter — NORTH EAST SCIENTIFIC INC

Recent recalls

DateFirmReason
2025-08-29Northeast Scientific Inc.Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29Northeast Scientific Inc.Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29Northeast Scientific Inc.Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29Northeast Scientific Inc.Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29Northeast Scientific Inc.Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29Northeast Scientific Inc.Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29Northeast Scientific Inc.Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
2025-08-29Northeast Scientific Inc.Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.