Atlas FDA

RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782,

FDA 510(k) clearance K021455 · decided 2002-08-02

Clearance details

K-number
K021455
Device name
RAPIDO GUIDING CATHETER, 6F MODEL# 6776; RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782,
Applicant
Guidant Corp.
Decision
Substantially Equivalent
Date received
2002-05-06
Decision date
2002-08-02
Days to decision
88 days
Clearance type
Traditional
Product code
DQY
Device class
2
Regulation number
870.1250
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
St Paul, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Guidant RAPIDO Cut-Away Guiding Catheter, 6F. Part Numbers: 66676-201 and 667552-100. For recall (Z-2793-2011)Abbott Vascular2011-07-12
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length recall (Z-0790-04)Guidant Corp-Cpi Division2004-07-20
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length recall (Z-0791-04)Guidant Corp-Cpi Division2004-07-20
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length recall (Z-0792-04)Guidant Corp-Cpi Division2004-07-20
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length recall (Z-0793-04)Guidant Corp-Cpi Division2004-07-20
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length recall (Z-0794-04)Guidant Corp-Cpi Division2004-07-20
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length recall (Z-0795-04)Guidant Corp-Cpi Division2004-07-20
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length recall (Z-0796-04)Guidant Corp-Cpi Division2004-07-20
Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 5 recall (Z-0797-04)Guidant Corp-Cpi Division2004-07-20
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length recall (Z-0798-04)Guidant Corp-Cpi Division2004-07-20
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length recall (Z-0799-04)Guidant Corp-Cpi Division2004-07-20
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length recall (Z-0800-04)Guidant Corp-Cpi Division2004-07-20
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length recall (Z-0801-04)Guidant Corp-Cpi Division2004-07-20
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Lenght recall (Z-0802-04)Guidant Corp-Cpi Division2004-07-20
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length recall (Z-0803-04)Guidant Corp-Cpi Division2004-07-20
Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Lenght 5 recall (Z-0804-04)Guidant Corp-Cpi Division2004-07-20
Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 5 recall (Z-0805-04)Guidant Corp-Cpi Division2004-07-20
Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 5 recall (Z-0806-04)Guidant Corp-Cpi Division2004-07-20

PMA approvals by this applicant

RecordFirmDate
VALITUDE™ (Model U125) VALITUDE™ X4 (Model U128) VISIONIST™ (Models U225, U226) VISIONIST™ X4 (Model U228) Firmware Vers (P030005/S250)Guidant Corp.2025-12-19
VALITUDE™ (Model U125); VALITUDE X4 (Model U128); VISIONIST™ (Models U225, U226); VISIONIST X4 (Model U228) (P030005/S251)Guidant Corp.2025-12-17
U125 VALITUDE™ CRT-P,U128 VALITUDE™ X4 CRT-P,U225 VISIONIST™ CRT-P,U226 VISIONIST™ CRT-P,U228 VISIONIST™ X4 CRT-P (P030005/S249)Guidant Corp.2025-10-22
Accolade Cardiac Resynchronization Therapy Pacemakers, VALITUDE (Model U125); VALITUDE X4 (Model U128); VISIONIST (Model (P030005/S248)Guidant Corp.2025-09-22
VALITUDE™ (Model U125); VALITUDE™ X4 (Model U128); VISIONIST™ (Models U225, U226); VISIONIST™ X4 (Model U228) (P030005/S246)Guidant Corp.2025-07-11
Valitude CRT-P; Valitude X4 CRT-P; Visionist CRT-P; Visionisnt X4 CRT-P (P030005/S245)Guidant Corp.2025-04-11
CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE (P030005/S244)Guidant Corp.2024-12-18
U125 VALITUDE CRT-P, U128 VALITUDE X4 CRT-P, U225 VISIONIST CRT-P, U226 VISIONIST CRT-P, U228 VISIONIST X4 CRT-P (P030005/S243)Guidant Corp.2024-11-25