← Product Code [FOZ](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ) · K960051 # NIPRO SAFELET CATH (K960051) _Nissho Corp. · FOZ · Mar 28, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ/K960051 ## Device Facts - **Applicant:** Nissho Corp. - **Product Code:** [FOZ](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ.md) - **Decision Date:** Mar 28, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5200 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## Indications for 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). ## Regulatory 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](/device/K895768.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ/K960051](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FOZ/K960051) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com