Who is the manufacturer of LAGUNA SOFTIP DIAGNOSTIC CATHETERS?

Boston Scientific Scimed, Inc. filed the 510(k) submission for LAGUNA SOFTIP DIAGNOSTIC CATHETERS (K961499).

What is the FDA product code for LAGUNA SOFTIP DIAGNOSTIC CATHETERS?

DQO. It is classified under 21 CFR 870.1200 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for LAGUNA SOFTIP DIAGNOSTIC CATHETERS?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like LAGUNA SOFTIP DIAGNOSTIC CATHETERS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LAGUNA SOFTIP DIAGNOSTIC CATHETERS

Q: What are the predicate devices for LAGUNA SOFTIP DIAGNOSTIC CATHETERS?

Softip® High Flow diagnostic catheter (5 FR, 7 FR); INFINITI™ diagnostic catheter (5 FR); SUPER TORQUEPLUS™ diagnostic catheter (7 FR); GUIDEZILLA™ Softip® guiding catheters.

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

Intended 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

Related Devices

K122937 — SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) · Cook, Inc. · Dec 14, 2012
K191608 — Impress Angiographic Catheter · Merit Medical Systems, Inc. · Jul 16, 2019
K970854 — 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER · Cordis Corp. · Sep 30, 1997
K172635 — High-Flo Silver Polyethylene Catheter · Cook Incorporated · Apr 3, 2018
K180286 — Polyethylene Catheter · Cook Incorporated · Oct 26, 2018

Submission Summary (Full Text)

{0} 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.