Who is the manufacturer of NIPRO SAFELET CATH?

Nissho Corp. filed the 510(k) submission for NIPRO SAFELET CATH (K960051).

What is the FDA product code for NIPRO SAFELET CATH?

FOZ. It is classified under 21 CFR 880.5200 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for NIPRO SAFELET CATH?

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

What are the predicate devices for NIPRO SAFELET CATH?

Exel Safelet Catheter (K895768).

Who can help prepare an FDA 510(k) submission like NIPRO SAFELET CATH?

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.

NIPRO SAFELET CATH

K960051 · Nissho Corp. · FOZ · Mar 28, 1996 · General Hospital

Device Facts

Record ID	K960051
Device Name	NIPRO SAFELET CATH
Applicant	Nissho Corp.
Product Code	FOZ · General Hospital
Decision Date	Mar 28, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5200
Device Class	Class 2

Intended Use

The Nipro Safelet Cath is intended to be inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously.

Device Story

Intravascular catheter for short-term vascular access; used for blood sampling, blood pressure monitoring, or IV fluid administration. Device consists of beveled cannula with proximal filter cap; available in long (1.5-2.5 inch needle) and short (0.75-1.25 inch needle) configurations; offered in 14, 16, 18, 20, 22, and 24 gauge sizes. Operated by clinicians in clinical settings. Device provides access to vascular system; facilitates fluid delivery or diagnostic monitoring.

Clinical Evidence

No clinical data; substantial equivalence based on identical design and technical characteristics to the predicate device.

Technological Characteristics

Intravascular catheter; beveled cannula tip; proximal filter cap. Available in 14-24 gauge sizes; needle lengths 0.75-2.5 inches. Short-term use (<30 days).

Indications for Use

Indicated for patients requiring short-term (less than 30 days) vascular access for blood sampling, blood pressure monitoring, or intravenous fluid administration.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

Exel Safelet Catheter (K895768)

Related Devices

K013287 — NIPRO SAFELET CATH · Nipro Medical Corp. · Dec 3, 2001
K193278 — MedSource CathMED IV Catheter · Medsource Labs · Aug 7, 2020
K022756 — NIPRO BIO-FLEX CATHETER · Nipro Medical Corp. · Oct 18, 2002
K071382 — SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50, 1.77,1.88',2, 1.25, 1.50, 1.77, · Shinchang Medical Co., Ltd. · Oct 16, 2007
K112290 — SUPERCATH Z3V · Togo Medikit Co., Ltd. · Apr 16, 2012

Submission Summary (Full Text)

{0} Nipro NISSHO CORPORATION K960051 7205 Corporate Center Drive Suite 305 Miami, Florida 33126 Tel: (305) 599-7174 Fax: (305) 599-8454 # SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO SAFELET CATH §807.92 (a)(1) Contact Person: Luis Candelario General Manager Date of Summary Preparation: January 3, 1996 §807.92 (a)(2) Trade Name: Nipro Safelet Cath Common Name: Intravascular catheter Classification Name: Intravascular catheter (for short-term use) (§880.5200) §807.92 (a)(3) Legally Marketed Substantially Equivalent Device: Exel Safelet Catheter, Exel International, Inc. (K895768) §807.92 (a)(4) Description of Device: The devices that we intend to market are intravascular catheters as described in 21 CFR 880.5200. These devices are identical to those already marketed by Exel International, Inc. under K895768. Two types of catheters will be available: the container case types L (long) and S (short). Type L catheters have needles 1½ to 2½ inches long and Type S have needles ¾ to 1¼ inches long. Six gauges of catheters are described here (14, 16, 18, 20, 22, and 24 gauge). The tip of the cannula is beveled. The proximal end of the catheter has a filter cap. {1} §807.92 (a)(5) Intended Use: The Nipro Safelet Cath is intended to be inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. §807.92 (a)(6) Comparison of Technical Characteristics: The Nissho and Exel devices are exactly the same devices, therefore, all technical characteristics are identical.