TERUMO MEDICAL CORPORATION RSM07 GLIDEACCESS

Amplatz Type Renal Dilator/Sheath Set

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Check-Flo Performer Introducer

Check-Flo Performer Introducer

Check-Flo Performer Introducer

Check-Flo Performer Introducer

Valved Peelable PTFE Introducer

Amplatz Type Renal Dilator/Sheath Set

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.