Percor Stat-Dl 9.5 Fr W/Opt Insert W/O Intro Sheat
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K905056 FDA 510(k)
- FDA Product Code
- DSP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3535 FDA 510(k)
- Regulation Number
- 870.3535 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Percor Stat-Dl is an intra-aortic balloon and control system designed for cardiovascular applications. It functions as a balloon catheter system used to provide circulatory support.
This device is classified as a Class 2 medical device under regulation number 870.3535. It has received FDA 510(k) clearance via the traditional pathway under K-number K905056.
Frequently asked questions
What is the primary function of the Percor Stat-DL?
The Percor Stat-DL is an intra-aortic balloon and control system designed for cardiovascular applications. It functions as a balloon catheter system specifically used to provide circulatory support for patients.
What is the regulatory status of this device?
The Percor Stat-DL is classified as a Class 2 medical device under regulation number 870.3535. It has received FDA 510(k) clearance via the traditional pathway under K-number K905056.
What are the physical specifications of this balloon catheter?
This specific model is a 9.5 Fr device. It is supplied with an optional insert but does not include an introducer sheath.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Percor Stat-dl 9.5 Fr W/Opt Insert W/O Intro Sheat, Percor Stat-dl 9.5 Fr W/Opt Insert W/O Intro Sheat, K980780 FDA 510 (k) - DATASCOPE PERCOR STAT-DL 9.5 FR. 25, Datascope Percor Stat-dl 9.5 Fr. 25, 34 and 40cc Intra-aoric Balloons ..., PDF K964987 - Datascope Percor Stat - Dl 9.5 Fr. 25 and 40cc Intra-aortic ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K905056 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Datascope Corp.
Sources (1)
- FDA 510(k) K905056 24 fields · synced Sep 25, 2026