Oscor Inc.

Address:3816 Desoto Blvd,PALM HARBOR,FL,34683,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

INTRODUCER, CATHETER (DYB) (8) CABLE, ELECTRODE (IKD) (1) PULSE-GENERATOR, PACEMAKER, EXTERNAL (DTE) (1)

Premarket Exempt

Clear

5391 - 00643169382978 Catalog Number : 5391

Device Description : Single Chamber External Pacemaker

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DTE

Prescription Use : Yes

Device Count : 1

ATAR - 00643169382985 Catalog Number : 53912

Device Description : Reusable Extension Cable

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Arrive™ Braided Transseptal Sheath - 00643169530584 Catalog Number : 990061-055

Device Description : Braided Transseptal Sheath, 10F

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Arrive™ Braided Transseptal Sheath - 00643169530591 Catalog Number : 990061-070

Device Description : Braided Transseptal Sheath, 10F

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Arrive™ Braided Transseptal Sheath - 00643169530614 Catalog Number : 990061-120

Device Description : Braided Transseptal Sheath, 10F

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Arrive™ Braided Transseptal Sheath - 00643169530621 Catalog Number : 990079-055

Device Description : Braided Transseptal Sheath, 10F

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Arrive™ Braided Transseptal Sheath - 00643169530638 Catalog Number : 990079-070

Device Description : Braided Transseptal Sheath, 10F

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Arrive™ Braided Transseptal Sheath - 00643169530645 Catalog Number : 990079-090

Device Description : Braided Transseptal Sheath, 10F

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

TourGuide™ Steerable Sheath - 00643169936232 Catalog Number : TG0659009

Device Description : Steerable Sheath, 6.5F

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

TourGuide™ Steerable Sheath - 00643169936249 Catalog Number : TG0709009

Device Description : Steerable Sheath, 7F

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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