ACIST Navvus®II Catheter

FDA UDI

Class II (US FDA UDI)

by ACIST Medical Systems, Inc.

Identity

Trade Name: ACIST Navvus®II Catheter FDA UDI
Generic Name: Catheter-tip transducer, pressure FDA UDI
Device Name: Navvus II Catheter, p/n 701711-003 FDA UDI
Model / Reference: 016675 FDA UDI
Description: Navvus II Catheter, p/n 701711-003 FDA UDI

Identifiers

Primary DI / UDI-DI: 10841716103244 FDA UDI
510(k) Number: K190473 FDA UDI
FDA Product Code: OBI FDA UDI
GMDN Term: Catheter-tip transducer, pressure FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Catheter-tip transducer, pressure

ACIST Navvus®II Catheter by ACIST Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Catheter-tip transducer, pressure.

Mikro-Tip Catheter Pulse Transducer — Millar LLC. · Class II
PressureWire™ — ST. JUDE MEDICAL, INC. · Class II
OptoWire — Opsens · Class II
PressureWire™ — ST. JUDE MEDICAL, INC. · Class II
OptoWire — Opsens · Class II
PrimeWire Prestige Pressure Guide Wire 185cm JTIP — Volcarica S.R.L. · Class II
PressureWire™ — LIGHTLAB IMAGING, INC. · Class II
PrimeWire Prestige Pressure Guide Wire 185cm ST — Volcarica S.R.L. · Class II

Cleared under the same submission

K190473 also covers:

ACIST Navvus®II Catheter — ACIST Medical Systems, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: ACIST Medical Systems, Inc.

Sources (1)

FDA UDI 3a970bc8-faa7-49a8-8311-effb788bbf08 35 fields · synced Jun 8, 2026