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PathBuilder Steerable Introducer

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K211530

by Shanghai Microport Ep Medtech Co., Ltd.

Identity

Trade Name
PathBuilder Steerable Introducer FDA UDI
Generic Name
Cardiac transseptal access set FDA UDI
Model / Reference
C.GK.S61 FDA UDI

Identifiers

Primary DI / UDI-DI
06952450970065 FDA UDI
510(k) Number
K211530 FDA 510(k)FDA UDI
FDA Product Code
DYB FDA 510(k)FDA UDI
GMDN Term
Cardiac transseptal access set FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 870.1340 FDA 510(k)
Regulation Number
870.1340 FDA 510(k)FDA UDI
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

PathBuilder Steerable Introducer by Shanghai Microport Ep Medtech Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shanghai Microport Ep Medtech Co., Ltd.

Sources (2)

  • FDA 510(k) K211530 24 fields · synced Jun 18, 2026
  • FDA UDI e1d27ffc-113f-4993-aa70-d9434df842c8 33 fields · synced May 26, 2026