BD Nexiva™ Closed IV Catheter System
Device Facts
| Record ID | K243403 |
|---|---|
| Device Name | BD Nexiva™ Closed IV Catheter System |
| Applicant | Becton Dickinson Infusion Therapy Systems, Inc. |
| Product Code | FOZ · General Hospital |
| Decision Date | Jul 25, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5200 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
BD Nexiva™ Closed IV Catheter System - Single Port BD Nexiva™ Closed IV Catheter System is intended to be inserted into a patient’s peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed. BD Nexiva™ Closed IV Catheter System - Dual Port BD Nexiva™ Closed IV Catheter System is intended to be inserted into a patient’s peripheral vascular system for short term use to sample blood or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.
Device Story
Over-the-needle peripheral intravascular catheter system; includes radiopaque catheter, needle, needle shield, septum, stabilization platform, extension tubing, clamp, Luer adapter, and needle-free connector. Designed as a closed system to contain blood during insertion; septum wipes needle surface upon withdrawal to reduce blood exposure; passive needle protection mechanism prevents needlestick injuries. Features BD Instaflash™ technology for immediate blood visualization in catheter and extension tubing; vent plug prevents leakage. Used by clinicians in clinical settings for short-term vascular access. Output is established venous access for fluid delivery, blood sampling, or pressure monitoring. Benefits include reduced blood exposure risk and improved insertion success via flashback visualization.
Clinical Evidence
Bench testing only. Performance testing included Frequency Response, Kink Resistance, Blood Fill Time, ISO 80369-7, and ISO 11607-1 testing. All tests met predetermined acceptance criteria.
Technological Characteristics
Over-the-needle peripheral IV catheter. Materials: Polyurethane/Barium Sulfate (catheter), Stainless Steel (needle), Copolyester (adapter), Thermoplastic Elastomer (wings). Features integrated extension set, septum, and passive needle protection. Sterilization: Ethylene Oxide. Connectivity: None. Complies with ISO 80369-7 for small-bore connectors.
Indications for Use
Indicated for any patient population requiring short-term peripheral vascular access for blood sampling, fluid administration, or (single-port only) blood pressure monitoring. Contraindicated if vascular anatomy is inadequate for the procedure or therapy duration.
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
- BD Nexiva™ Closed IV Catheter System (K183399)
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
July 25, 2025
Becton Dickinson Infusion Therapy Systems Inc.
Amy Moore
Staff Regulatory Affairs Associate
9450 South State Street
Sandy, Utah 84070
Re: K243403
Trade/Device Name: BD Nexiva™ Closed IV Catheter System
Regulation Number: 21 CFR 880.5200
Regulation Name: Intravascular catheter
Regulatory Class: Class II
Product Code: FOZ
Dated: June 18, 2025
Received: June 18, 2025
Dear Amy Moore:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
{1}
K243403 - Amy Moore
Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
{2}
K243403 - Amy Moore
Page 3
Sincerely,
David Wolloscheck -S
David Wolloscheck, Ph.D.
Assistant Director
DHT3C: Division of Drug Delivery and
General Hospital Devices, and
Human Factors
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
{3}
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K243403
Device Name
BD Nexiva™ Closed IV Catheter System
Indications for Use (Describe)
BD Nexiva™ Closed IV Catheter System - Single Port
BD Nexiva™ Closed IV Catheter System is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.
BD Nexiva™ Closed IV Catheter System - Dual Port
BD Nexiva™ Closed IV Catheter System is intended to be inserted into a patient's peripheral vascular system for short term use to sample blood or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
# CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}
BDC
Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com
# K243403 - 510(k) Summary (21 CFR §807.92)
# BD Nexiva™ Closed IV Catheter System
| Submitter Information | Submitter Name: | Becton Dickinson Infusion Therapy Systems Inc. |
| --- | --- | --- |
| | Submitter Address: | 9450 South State Street, Sandy, Utah 84070 |
| | Contact Person: | Amy Moore, Staff Regulatory Affairs Specialist |
| | Email Address: | amy.moore@bd.com |
| | Phone Number: | (801) 522-5200 |
| | Date of Preparation: | July 25, 2025 |
| Subject Device | Trade Name: | BD Nexiva™ Closed IV Catheter System |
| | Common Name: | Short-term, less than 30 days, intravascular, therapeutic catheter |
| | Regulation Number: | 21 CFR 880.5200 |
| | Regulation Name: | Intravascular catheter |
| | Regulatory Class: | II |
| | Product Code: | FOZ (Primary); FPA (Secondary) |
| | Classification Panel: | General Hospital |
| Predicate Device | Trade Name: | BD Nexiva™ Closed IV Catheter System |
| | 510(k) Reference: | K183399 |
| | Common Name: | Short-term, less than 30 days, intravascular, therapeutic catheter |
| | Regulation Number: | 21 CFR 880.5200 |
| | Regulation Name: | Intravascular catheter |
| | Regulatory Class: | II |
| | Product Code: | FOZ (Primary); FPA (Secondary) |
| | Classification Panel: | General Hospital |
| Reason for Submission | The purpose of this submission is to notify the FDA of the following: • Defined or modified performance specifications for Blood Fill Time (Blood Sampling), Frequency Response (Blood Pressure Monitoring), Catheter Kink Resistance (Blood Pressure Monitoring), and ISO 80369-7 (in place of ISO 594-1 and ISO 594-2); • Narrowed Indications for Use for dual ported configurations to limit use to the peripheral venous system only to administer fluids and/or medications and sample blood. | |
| Device Description | BD Nexiva™ Closed IV Catheter Systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon™ catheter, needle, needle | |
{5}
Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com
shield, septum, stabilization platform, integrated extension tubing, clamp, Luer adapter (single or dual port), vent plug, and pre-attached needle-free connector (BD Q-Syte™ or BD MaxZero™) (dual port configurations only). The needle and catheter are protected by a needle cover. A BD Q-Syte™ Needle-free Connector, BD MaxZero™ Needle-free Connector, or end cap with protective cover is provided in the unit package (not available with all configurations).
The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury.
These devices have BD Instaflash™ needle technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and Luer connector are color coded to indicate catheter gauge size (24 GA (0.7 mm) = Yellow, 22 GA (0.9 mm) = Blue, 20 GA (1.1 mm) = Pink, 18 GA (1.3 mm) = Green).
## Indications for Use (21 CFR § 807.92(a)(5))
## BD Nexiva™ Closed IV Catheter System - Single Port
BD Nexiva™ Closed IV Catheter System is intended to be inserted into a patient’s peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.
## BD Nexiva™ Closed IV Catheter System - Dual Port
BD Nexiva™ Closed IV Catheter System is intended to be inserted into a patient’s peripheral vascular system for short term use to sample blood or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.
Page 2 of 6
{6}
Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com
Technological Characteristics
Technological characteristics of the subject device are substantially equivalent to the predicate device. The subject BD Nexiva™ Closed IV Catheter achieves its intended use based on the same technology and principles of operation as the predicate device.
A comparison of the subject and predicate device technological characteristics is provided in the table below.
| Attribute | SUBJECT
BD Nexiva™ Closed IV Catheter System | PREDICATE (K183399)
BD Nexiva™ Closed IV Catheter System | Substantially Equivalent? |
| --- | --- | --- | --- |
| Classification | 21 CFR 880.5200
Class II
FOZ - Intravascular Catheter (primary)
FPA – IV Administration Set (secondary) | 21 CFR 880.5200
Class II
FOZ - Intravascular Catheter (primary)
FPA – IV Administration Set (secondary) | Same as the predicate. |
| Indications for Use – Single Port Configurations | BD Nexiva™ Closed IV Catheter System is intended to be inserted into a patient’s peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed. | BD Nexiva™ Closed IV Catheter Systems are intended to be inserted into a patient’s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed. | Same as the predicate.
The addition of the word “peripheral” has been added for clarification only with no change to the substance, meaning or scope of the intended use of the device.
Additional minor wording changes with no change to the substance, meaning or scope. |
| Indications for Use – Dual Port Configurations | BD Nexiva™ Closed IV Catheter System is intended to be inserted into a patient’s peripheral vascular system for short term use to sample blood or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) | BD Nexiva™ Closed IV Catheter Systems are intended to be inserted into a patient’s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) | The Indications for Use for the BD Nexiva Closed IV Catheter System – Dual Port is being narrowed only to sample blood or administer fluids.
The addition of the word “peripheral” has been added for clarification only with no change to the substance, meaning or scope of the intended use of the device. Additional minor wording changes |
Page 3 of 6
{7}
Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com
| | when access ports not suitable for use with power injectors are removed.
Note: Blood pressure monitoring has been removed from Indications for Use. | pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed. | with no change to the substance, meaning or scope. |
| --- | --- | --- | --- |
| Fundamental Scientific Technology | Closed peripheral intravascular catheter system designed with an integrated extension set incorporating a single port or Y (dual)-port injection site. Incorporates Instaflash™ needle technology to assist with flashback visualization | Closed peripheral intravascular catheter system designed with an integrated extension set incorporating a single port or Y (dual)-port injection site. Incorporates Instaflash™ needle technology to assist with flashback visualization | Same as predicate. |
| Catheter Dimensions | Catheter Diameters 18 GA, 20 GA, 22 GA, 24 GA
Catheter Lengths 0.56 IN, 0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN | Catheter Diameters 18 GA, 20 GA, 22 GA, 24 GA
Catheter Lengths 0.56 IN, 0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN | Same as predicate |
| Product Configurations | • Single Port
• Single Port with MaxZero™
• Dual Port with Q-Syte™
• Dual Port with Q-Syte™ and End Cap
• Dual Port with MaxZero™ | • Single Port
• Single Port with MaxZero™
• Dual Port with Q-Syte™
• Dual Port with Q-Syte™ and End Cap
• Dual Port with MaxZero™ | Same as predicate |
| Sterilization Modality | Ethylene Oxide | Ethylene Oxide | Same as predicate |
| Comparison of Subject / Predicate Device Primary Device Component Materials | | | |
| Needle Cover | LDPE | LDPE | Same as predicate |
| Needle | Stainless Steel | Stainless Steel | There is no change to the material type; however, the grade of the stainless steel was modified.
This change does not raise any new or different questions of safety or effectiveness. |
| Catheter Tubing | Polyurethane + Barium Sulfate | Polyurethane + Barium Sulfate | Same as predicate |
| Catheter Adapter Wings | Thermoplastic Elastomer + Gauge-Specific Colorant
24GA (Yellow)
22GA (Blue)
20GA (Pink)
18GA (Green) | Thermoplastic Elastomer + Gauge-Specific Colorant
24GA (Yellow)
22GA (Blue)
20GA (Pink)
18GA (Green) | Same as predicate |
| Catheter Adapter | Copolyester | Copolyester | Same as predicate |
Page 4 of 6
{8}
Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com
| Wedge | Stainless Steel | Stainless Steel | Same as predicate |
| --- | --- | --- | --- |
| Septum Canister | Copolyester + Grey Colorant | Copolyester + Grey Colorant | Same as predicate |
| V-Clip | Stainless Steel with Parylene Coating | Stainless Steel with Parylene Coating | Same as predicate |
| Retention Washer | Stainless Steel | Stainless Steel | Same as predicate |
| Tip Shield | Polycarbonate + Grey Colorant | Polycarbonate + Grey Colorant | Same as predicate |
| Grip / Needle Hub | Polycarbonate + White Colorant | Polycarbonate + White Colorant | Same as predicate |
| Pinch Clamp | Acetal Copolymer | Acetal Copolymer | Same as predicate |
| Extension Tubing | Polyurethane | Polyurethane | Same as predicate |
| Vent Plug | Polypropylene + Acrylic Copolymer Filter | Polypropylene and Acrylic Copolymer Member | Same as predicate |
| Luer Adapter | Copolyester + Gauge-Specific Colorant | Copolyester + Gauge-Specific Colorant | Same as predicate |
| End Cap | Polypropylene + White Colorant | Polypropylene + White Colorant | Same as predicate |
| End Cap Protective Cover | HDPE + Blue Colorant | HDPE + Blue Colorant | Same as predicate |
| Q-Syte | Polycarbonate + Silicone with Parylene coating | Polycarbonate | Same as predicate |
| Q-Syte Protective Cover | Polypropylene + Blue Colorant | Polypropylene + Blue Colorant | Same as predicate |
| MaxZero | Polycarbonate + Silicone | Polycarbonate | Same as predicate |
| MaxZero Protective Cover | HDPE Polyethylene | HDPE Polyethylene | Same as predicate |
## Summary of Performance Tests
Performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate device. A risk analysis was conducted to assess the impact of the proposed modifications to the predicate device. When technological characteristics between the subject and predicate devices were found to be identical, results of performance testing conducted on the predicate devices were applied to the subject device. The performance tests listed below were conducted to ensure that the subject device meets specified design requirements:
- Frequency Response Testing,
- Kink Resistance Testing,
- Blood Fill Time Testing,
- ISO 80369-7 Testing, and
- ISO 11607-1 Testing.
Page 5 of 6
{9}
Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, Utah 84070 USA
bd.com
Per the design control requirements specified in 21 CFR §820.30, the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate devices.
**Summary of Substantial Equivalence**
Based on the indications for use, technological characteristics, and results of performance testing, the subject BD Nexiva Closed IV Catheter System has been demonstrated to be substantially equivalent to the predicate device.
Page 6 of 6
