Cambridge Heart, Inc.
South West Ranches, FL, US
Cambridge Heart, Inc. appears in FDA device records in South West Ranches, FL. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Cambridge Heart, Inc. between 1996 and 2010. The busiest year on record is 2001, with 7. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 2 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 7 |
| 2002 | 2 |
| 2005 | 1 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K100362 | CAMBRIDGE HEART OEM | DQK | Substantially Equivalent | |
| K050225 | HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM | DQK | Substantially Equivalent | |
| K022152 | HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS | DPS | Substantially Equivalent | |
| K022149 | CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 | DPS | Substantially Equivalent | |
| K013565 | CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 | DPS | Substantially Equivalent | |
| K013564 | MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS | DPS | Substantially Equivalent | |
| K012206 | ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM | DQK | Substantially Equivalent | |
| K011324 | CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM | DQK | Substantially Equivalent | |
| K010758 | HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS | DPS | Substantially Equivalent | |
| K010756 | CH 2000 CARDIAC DIAGNOSTIC SYSTEM | DQK | Substantially Equivalent | |
| K003492 | ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS | DQK | Substantially Equivalent | |
| K002230 | CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 | DRX | Substantially Equivalent | |
| K001034 | MODEL APS ALTERNANS PROCESSING SYSTEM | DPS | Substantially Equivalent | |
| K983102 | CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000 | DQK | Substantially Equivalent | |
| K981697 | CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM | DPS | Substantially Equivalent | |
| K962115 | CAMBRIDGE HEART HI-RES ECG ELECTRODE | DRX | Substantially Equivalent | |
| K950018 | CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM | DPS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1776-2010 | The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary for conducting a Microvolt Twave Alternans test. | Some kits contained a component with expiration date prior to the date of expiry on the outside of the kit. The user receives feedback of potential unreliable results at several stages during the test process, so any risk of unreliable results is low. | Terminated |
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.
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 Cambridge Heart, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain