Atlas FDA

MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S)

FDA 510(k) clearance K900515 · decided 1990-08-23

Clearance details

K-number
K900515
Device name
MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S)
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
1990-02-02
Decision date
1990-08-23
Days to decision
202 days
Clearance type
Traditional
Product code
DYB
Device class
2
Regulation number
870.1340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Minneapolis, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
NAMIC Dilator and Sheath (K253526)Medline Industries, LP2026-07-29
Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) (K261529)Hartman Medical Group, LLC2026-07-06
SimplGuide (K261242)Pendracare2026-06-25
Health Line Tearaway Introducer (K261950)Health Line International Corporation2026-06-22
FieldFlex Steerable Sheath (K261492)CenterPoint Systems, LLC2026-06-05
Echo Large Bore Introducer Sheath (K260606)Echo Medical, LLC2026-04-29
Introducer Sheath Set (K254248)Cardiocycle Medical(Suzhou) Co., Ltd.2026-04-23
Edwards eSheath+ introducer set (K254279)Edwards Lifesciences2026-04-17
Aventus Introducer Sheath (K260091)Inquis Medical2026-04-13
Protaryx Transseptal Puncture Device (PTX2-001) (K260839)Protaryx Medical, Inc.2026-04-10
AuST Steerable Sheath (K260942)CenterPoint Systems, LLC2026-04-07
VANES Delivery System (VDS) (K260459)Zoll Respicardia, Inc.2026-04-06

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent System Stent S (P160043/S094)Medtronic Vascular2026-06-05
RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P160043/S093)Medtronic Vascular2026-05-29
Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent System Stent S (P160043/S092)Medtronic Vascular2026-05-13
Endurant™ II/IIs Stent Graft System (P100021/S132)Medtronic Vascular2026-05-12
Onyx Frontier Zotarolimus Eluting Coronary Stent System (P160043/S090)Medtronic Vascular2026-03-25
Endurant™, Endurant™ II/lls Stent Graft System (P100021/S134)Medtronic Vascular2026-02-27
Valiant™ Thoracic Stent Graft with the Captivia™ Delivery System (P100040/S074)Medtronic Vascular2026-02-27
Endurant Stent Graft System; Endurant II/IIs Stent Graft System; Endurant II AUI Stent Graft System (P100021/S133)Medtronic Vascular2026-01-27