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Parafleet SC 018 PTA Balloon Dilatation Catheter

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref F35-030220-090

by BrosMed Medical Co., Ltd.

Identity

Trade Name
Parafleet SC 035 EUDAMED
Parafleet SC 018 PTA Balloon Dilatation Catheter FDA UDI
Generic Name
Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name
Atropos Pro / Parafleet SC 035 PTA Balloon Dilatation Catheter EUDAMED
Model / Reference
F35-030220-090 EUDAMED
rev 01 FDA UDI

Identifiers

Catalog Number
F35-030220-090 FDA UDI
Primary DI / UDI-DI
06942265517364 EUDAMEDFDA UDI
Basic UDI-DI
695848140065MK EUDAMED
510(k) Number
K243704 FDA UDI
FDA Product Code
LIT FDA UDI
EMDN Code
C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
GMDN Term
Peripheral angioplasty balloon catheter, basic FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
870.1250 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Parafleet SC 018 PTA Balloon Dilatation Catheter by BrosMed Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Cleared under the same submission

K243704 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BrosMed Medical Co., Ltd.

Sources (2)

  • FDA UDI 4679ed25-c4de-4fa3-8851-6780dd5d39c0 34 fields · synced Oct 7, 2026
  • EUDAMED af59afb6-7fbf-4656-bf38-5d07009ec1dc 61 fields · synced Jul 18, 2026