Panels › Cardiovascular › Product code DRF · Class 2
Catheter, Electrode Recording, Or Probe, Electrode Recording
Regulation 870.1220
2510(k)s in 12 months (186 all time)
0recalls in 12 months (26 all time)
19recalls that name a 510(k)
Top companies in DRF
| Company | 510(k)s | Recalls |
|---|---|---|
| Biosense Webster, Inc. | 19 | 15 |
| Boston Scientific | 14 | 5 |
| St Jude Medical | 14 | 1 |
| Ep Technologies, Inc. | 12 | 0 |
| C.R. Bard, Inc. | 11 | 0 |
| Irvine Biomedical, Inc. | 11 | 0 |
| Cordis Webster, Inc. | 8 | 0 |
| Innovative Health, LLC | 6 | 0 |
| Medtronic | 5 | 1 |
| Cardima, Inc. | 5 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2020 | Irvine Biomedical Inc, a St. Jude Medical Co. Inquiry Steerable Diagnostic Catheter, REF: IBI-87002 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and card Terminated |
DRF | K961924 |
| Aug 24, 2020 | Irvine Biomedical Inc, a St. Jude Medical Co. Inquiry Steerable Diagnostic Catheter, REF: IBI-81104 - Product Usage: INDICATIONS FOR USE The Inquiry fixed curve and steerable electrophysiology catheters are used for electrogram recording and card Terminated |
DRF | K961924 |
| Jul 30, 2018 | Arrow International Inc ARROW Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm
Product Code: AI-06210-S
Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studie Terminated |
DRF | K945229 |
| Nov 2, 2015 | Medtronic Inc. Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard Terminated |
DRF | K102588 |
| Apr 27, 2015 | Biosense Webster, Inc. WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only.
Catalog No: 01085413 Terminated |
DRF | None listed |
| Mar 3, 2015 | Biosense Webster, Inc. LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06.
LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological Terminated |
DRF | K130602 |
| Dec 10, 2014 | Boston Scientific Corp IntellaMap Orion High Resolution Mapping Catheter;
Material number: M004RC64S0; Catalog number RC64S;
Is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac stru Terminated |
DRF | K122461 |
| Nov 6, 2014 | St Jude Medical St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353 Terminated |
DRF | K894500 |
| Jun 28, 2013 | Biosense Webster, Inc. 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S.
Designed to facilitate electrophysiological mapping of the atria of the heart. Terminated |
DRF | K113213 |
| May 22, 2012 | Biosense Webster, Inc. EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter
Cardiovascular catheter for use in electrophysiological diagnosis and ablation. Terminated |
DRF | K090898 K101345 |
| Aug 18, 2011 | Biosense Webster, Inc. Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog Number D728260RT
Duo-Decapolar Electrophysiology Catheter has been designed for electrophysiological mapping o Terminated |
DRF | K953768 |
| Aug 18, 2011 | Biosense Webster, Inc. ISMUS Catheter Mapping Catheter with Auto ID Technology, Manufacturing Part Number D-1171-34-S, Catalog Number D7R20P14CT
The ISMUS Catheter with Auto ID Technology has been designed for electrophysi Terminated |
DRF | K953768 |
| Jun 27, 2011 | Biosense Webster, Inc. LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-1220-82-S, Catalog Numbers 07L2015CT
The affected catheters are indicated for multiple electrode electrophysiologic Terminated |
DRF | K002333 |
| Jun 27, 2011 | Biosense Webster, Inc. LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-122081-
S, Catalog Numbers D7L2020CT
The affected catheters are indicated for multiple electrode electrophysiologic Terminated |
DRF | K002333 |
| Jun 27, 2011 | Biosense Webster, Inc. HALO Catheter with Auto 10 Technology, Part Number D-1160-43-S, Catalog Number
D7T20282CT
The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structure Terminated |
DRF | K953768 |
| Jun 27, 2011 | Biosense Webster, Inc. ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog #
D7R20P14CT
The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac Terminated |
DRF | K953768 |
| Aug 30, 2008 | Boston Scientific Corp Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific Corporation, San Jose, CA - Cardiac Catheter Terminated |
DRF | None listed |
| Aug 30, 2008 | Boston Scientific Corp Boston Scientific SteeroCath-T Ablation Catheter. This catheter is indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product in Terminated |
DRF | None listed |
| Aug 25, 2008 | Biosense Webster Inc Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the Terminated |
DRF | K031161 |
| Aug 25, 2008 | Biosense Webster Inc Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the Terminated |
DRF | K031161 |
| Aug 22, 2007 | Boston Scientific Corp Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0 Terminated |
DRF | K924163 |
| Oct 19, 2005 | Boston Scientific Boston Scientific brand Position Acquisition Module (PAM), a component of Realtime Position Management (RPM) System,
Catalog/Model Numbers: 8200010, 8200TWA0 Terminated |
DRF | None listed |
| Sep 2, 2004 | Biosense Webster, Inc. Deflectable Tip Catheter for cardiac mapping.
Mfg Part # Catalog # EU Part #
D-1078-35-S 107835S SW1078-035;
D-1078-63-S D5S06AL252RT 36A-07Q;
Terminated |
DRF | None listed |
| Aug 18, 2004 | Bio-Detek, Inc. Zoll Pediatric Electrodes labeled: Pedi Padz Multi-Function Electrode
part Number: 8900-2065 Terminated |
DRF | K915159 |
| Aug 7, 2004 | Biosense Webster, Inc. Stockert 70 Radio Frequency Ablation Generator Terminated |
DRF | None listed |
| Jul 20, 2004 | Biosense Webster, Inc. Quickcable Autoclaveable Cable
Electrode Cable Terminated |
DRF | None listed |
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