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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K232144

Sterile Products of the APTUS System · Medartis AG · decided 2023-08-18 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
APTUSA-4750.33SMedartis AGHRS07630037890508
APTUSA-5700.10/1SMedartis AGHWC07630037881568
APTUSA-5500.30/1SMedartis AGHWC07630037881353
APTUSA-5400.10/1SMedartis AGHWC07630037880240
APTUSA-4300.11SMedartis AGHRS07630037862796
APTUSA-4655.22SMedartis AGHRS07630037889878
APTUSA-4645.23SMedartis AGHRS07630037889649
APTUSA-5450.14/1SMedartis AGHWC07630037880585
APTUSA-4760.08SMedartis AGHTY07630037890881
APTUSA-4750.123SMedartis AGHRS07630037890256
APTUSA-4750.61SMedartis AGHRS07630037890621
APTUSA-4750.44SMedartis AGHRS07630037890591
APTUSA-4750.01SMedartis AGHRS07630037890065
APTUSA-4750.80SMedartis AGHRS07630037890775
APTUSA-4750.134SMedartis AGHRS07630037890331
APTUSA-4640.31SMedartis AGHRS07630037889540
APTUSA-5750.08/1SMedartis AGHWC07630037881971
APTUSA-5600.10/1SMedartis AGHWC07630037881469
APTUSA-5100.14/1SMedartis AGHWC07630037878865
APTUSA-4300.21SMedartis AGHRS07630037862871
APTUSA-4645.10SMedartis AGHRS07630037889595
APTUSA-5750.28/1SMedartis AGHWC07630037882275
APTUSA-4650.62SMedartis AGHRS07630037889731
APTUSA-4645.03SMedartis AGHTN07630037889571
APTUSA-5750.20/1SMedartis AGHWC07630037882152