# Preface 301803A

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/preface-301803a>
- Manufacturer: [Biosense Webster Inc](https://devicerts.com/manufacturers/biosense-webster-inc) (United States)
- Name in the registry: PREFACE 301803A
- Device class: Class III (EU MDR); Class II (US FDA)
- FDA product code: DYB
- EMDN: C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED
- GMDN: Vascular catheter introduction set, nonimplantable (58865)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 08468350a0029FD · UDI-DI 10846835000023 · registered 2026-01-05 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 10846835000023 · listed 2016-09-16 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K982740 · decision 1998-08-28 · decision SESE · status: Active · from GUDID

## EU certificates

- MDR 787990 · Technical documentation · MDR · notified body BSI Group The Netherlands B.V. · issued 2025-05-16 · expires 2029-05-16 · status: amended

## Recalls

No recall on record.

## Identity

- Trade name: PREFACE Sheath [EUDAMED]; PREFACE [FDA GUDID (AccessGUDID)]
- Generic name: Vascular catheter introduction set, nonimplantable [FDA GUDID (AccessGUDID)]
- Model / Ref / Catalog: 301803A [EUDAMED, FDA GUDID (AccessGUDID)]; PREFACE [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 10846835000023 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 08468350a0029FD [EUDAMED]
- 510(k) Number: K982740 [FDA GUDID (AccessGUDID)]
- FDA product code: DYB [FDA GUDID (AccessGUDID)]
- EMDN code: C0502 [EUDAMED]
- GMDN term: Vascular catheter introduction set, nonimplantable (58865) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class III [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 870.1340 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Belgium [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Supplied sterile: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: Yes [FDA GUDID (AccessGUDID)]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Convenience kit: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Preface 301803A, Biosense Webster Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/preface-301803a (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-11-09
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/preface-301803a.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/preface-301803a
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.