K961499 · Boston Scientific Scimed, Inc. · DQO · Oct 17, 1996 · Cardiovascular
Device Facts
Record ID
K961499
Device Name
LAGUNA SOFTIP DIAGNOSTIC CATHETERS
Applicant
Boston Scientific Scimed, Inc.
Product Code
DQO · Cardiovascular
Decision Date
Oct 17, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.1200
Device Class
Class 2
Indications for Use
The LAGUNA™ Softip® diagnostic catheter is designed for delivering radiopaque media to selected sites in the vascular system.
Device Story
Diagnostic catheter; 5, 6, and 7 French sizes; multiple distal stem configurations/lengths. Used for delivery of radiopaque media to vascular sites. Physician-operated in clinical setting. Provides vascular access for contrast media injection. Benefits patient by enabling diagnostic imaging of vascular system.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Catheter available in 5, 6, 7 FR sizes. Features include variable distal stem configurations and handling characteristics. Testing performed: bond strength, flexural rigidity, bodystock force delay, tip shape recovery, flow rate, pressure injection/leak, output torque, input torque to failure, distal pressure.
Indications for Use
Indicated for patients requiring delivery of radiopaque media to selected sites in the vascular system.
Regulatory Classification
Identification
An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.
Predicate Devices
Softip® High Flow diagnostic catheter (5 FR, 7 FR)
INFINITI™ diagnostic catheter (5 FR)
SUPER TORQUEPLUS™ diagnostic catheter (7 FR)
GUIDEZILLA™ Softip® guiding catheters
Submission Summary (Full Text)
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Pfizer Hospital Products Group
5905 Nathan Lane
Minneapolis, MN 55442
Tel 612 550 5500 Fax 612 550 5771
Pfizer
OCT 17 1996
SCHNEIDER
510(k) Summary for
LAGUNA™ Softip® diagnostic catheter
Date Prepared: April 17, 1996
K 961499
Sponsor: Schneider (USA) Inc
5905 Nathan Lane
Plymouth, MN 55442
Phone: (612)550-5500
Contact: Maria Brittle
Sr. Regulatory Affairs Specialist
Trade/Proprietary Name: LAGUNA™ Softip® diagnostic catheter
Classification: Class II
Equivalent Devices
Softip® High Flow diagnostic catheter (5 FR, 7 FR)
INFINITI™ diagnostic catheter (5 FR)
SUPER TORQUEPLUS™ diagnostic catheter (7 FR)
GUIDEZILLA™ Softip® guiding catheters (packaging & sterilization)
Device Description
The LAGUNA™ diagnostic catheter is manufactured in three French sizes (5 FR, 6 FR and 7 FR) and multiple distal stem configurations and lengths. In addition, within each French size, catheters will be offered with differing handling characteristics to allow flexibility in meeting physician preferences.
Intended Use
The LAGUNA™ Softip® diagnostic catheter is designed for delivering radiopaque media to selected sites in the vascular system.
Technological Characteristics
The following tests were performed on the LAGUNA™ Softip® diagnostic catheters and approved predicate device to show equivalence: bond strength tests, flexural rigidity, bodystock force delay, tip shape recovery, flow rate, pressure injection/leak test, output torque, input torque to failure and distal pressure testing.
The results of these tests indicate that the LAGUNA™ Softip® diagnostic catheters are equivalent to the previously approved predicate device and is therefore safe for its intended use.
