PPMDM

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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

Trocar (DRC) (7) Introducer, Catheter (DYB) (2)

Premarket Exempt

Clear

Transseptal Introducer - 00858769006333 Catalog Number : TSIL08581

Device Description : 8.5F x 81cm Transseptal Introducer Set L0 Curve

Device Class : 2

Duns Number: 081047841

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Transseptal Introducer - 00858769006340 Catalog Number : TSIL18581

Device Description : 8.5F x 81cm Transseptal Introducer Set L1 Curve

Device Class : 2

Duns Number: 081047841

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

SafeSept Blunt Needle - 00858769006357 Catalog Number : SBN071

Device Description : 71cm Transseptal Extended Cannula Curve 0

Device Class :

Duns Number: 081047841

Premarket Exempt : No

Product Code : DRC

Prescription Use : Yes

Device Count : 1

SafeSept Blunt Needle - 00858769006364 Catalog Number : SBN089

Device Description : 89cm Transseptal Extended Cannula Curve 0

Device Class : 2

Duns Number: 081047841

Premarket Exempt : No

Product Code : DRC

Prescription Use : Yes

Device Count : 1

SafeSept Blunt Needle - 00858769006371 Catalog Number : SBN098

Device Description : 98cm Transseptal Extended Cannula Curve 0

Device Class : 2

Duns Number: 081047841

Premarket Exempt : No

Product Code : DRC

Prescription Use : Yes

Device Count : 1

SafeSept Blunt Needle - 00858769006388 Catalog Number : SBN171

Device Description : 71cm Transseptal Extended Cannula Curve 1

Device Class : 2

Duns Number: 081047841

Premarket Exempt : No

Product Code : DRC

Prescription Use : Yes

Device Count : 1

SafeSept Blunt Needle - 00858769006395 Catalog Number : SBN189

Device Description : 89cm Transseptal Extended Cannula Curve 1

Device Class : 2

Duns Number: 081047841

Premarket Exempt : No

Product Code : DRC

Prescription Use : Yes

Device Count : 1

SafeSept Blunt Needle - 00858769006401 Catalog Number : SBN198

Device Description : 98cm Transseptal Extended Cannula Curve 1

Device Class : 2

Duns Number: 081047841

Premarket Exempt : No

Product Code : DRC

Prescription Use : Yes

Device Count : 1

SafeSept Transseptal Guidewire - 00858769006418 Catalog Number : SS-140

Device Description : 0.018" Transseptal Guidewire

Device Class : 2

Duns Number: 081047841

Premarket Exempt : No

Product Code : DRC

Prescription Use : Yes

Device Count : 1

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