510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Chf Solutions, Inc.

Washington, DC, US

Chf Solutions, Inc. appears in FDA device records in Washington, DC. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
13
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 13 510(k) clearances for Chf Solutions, Inc. between 2002 and 2020. The busiest year on record is 2003, with 3. The most recent is 2020, with 1.

Clearances by year, as a table
510(k) clearance decisions for Chf Solutions, Inc., by decision year
YearClearances
20022
20033
20042
20051
20062
20072
20201
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K192756Aquadex FlexFlow System 2.0KDISubstantially Equivalent
K071854AQUADEX FLEXFLOW SYSTEMKDISubstantially Equivalent
K070512MODIFICATION TO AQUADEX FLEXFLOW SYSTEMKDISubstantially Equivalent
K062922MODIFICATION TO AQUADEX FLEXFLOW SYSTEMKDISubstantially Equivalent
K060008AQUADEX FLEXFLOW SYSTEMKDISubstantially Equivalent
K050609AQUADEX SYSTEMKDISubstantially Equivalent
K0417915.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)NQJSubstantially Equivalent
K040489AQUADEX SYSTEM 100, MODEL A1100KDISubstantially Equivalent
K031689DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)NQJSubstantially Equivalent
K023874SYSTEM 100 ULTRAFILTRATION CATHETERKDISubstantially Equivalent
K024124SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORTKDISubstantially Equivalent
K023224INFUSION CATHETER EXTENSION SETKDISubstantially Equivalent
K013733SYSTEM 100; S-100 ULTRAFILTRATION CONSOLE; BDT 500 ULTRAFILTRATION SETKDISubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Chf Solutions, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Chf Solutions, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

Data as of , FDA export datePage updated Source: openFDA, public domain