D-STAT RADIAL HEMOSTATIC BAND

K050133 · Vascular Solutions, Inc. · QSX · Feb 18, 2005 · SU

Device Facts

• Record ID: K050133
• Device Name: D-STAT RADIAL HEMOSTATIC BAND
• Applicant: Vascular Solutions, Inc.
• Product Code: QSX · SU
• Decision Date: Feb 18, 2005
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The D-Stat Radial Hemostatic Band is applied topically and is indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.

Device Story

D-Stat Radial Hemostatic Band is a topical hemostatic device used to control bleeding at vascular access sites. It consists of a lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride, secured to an adjustable retention strap and retainer. The device is applied by a clinician to the puncture site. Once hemostasis is achieved, the lyophilized pad can be detached from the retention strap and secured with an adhesive bandage for up to 24 hours. The device facilitates patient recovery by accelerating hemostasis at catheter or tube insertion sites.

Clinical Evidence

Bench testing only. Testing included assessment of the ability to separate the lyophilized pad from the retainer and a biocompatibility assessment of new materials.

Technological Characteristics

Device comprises a lyophilized pad containing thrombin, sodium carboxymethylcellulose, and calcium chloride. Mechanical components include an adjustable retention strap and retainer. The device is designed for topical application to vascular access sites.

Indications for Use

Indicated for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes in patients requiring topical hemostasis.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• Vascular Solutions D-Stat Radial Hemostatic Band (K030836)
• Vascular Solutions D-Stat Dry Hemostatic Bandage (K030836)

Submission Summary (Full Text)

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February 10, 2023

Vascular Solutions, Inc. Linda Busklein Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K050133

Trade/Device Name: D-Stat Dry Radial Hemostatic Band Regulatory Class: Unclassified Product Code: QSX

Dear Linda Busklein:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 18, 2005. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSX.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, [e-mail].

Sincerely,

## Julie A. Morabito -S

Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

FEB 1 8 2005

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Linda Busklein Senior Regulatory Affairs Associate Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K050133

K050133
Trade/Device Name: D-Stat Dry Radial Hemostatic Band Regulatory Class: Unclassified Product Code: FRO Dated: January 20, 2005 Received: January 21, 2005

Dear Ms. Busklein:

We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section 5 ro(x) premainted in the may be needed in interstate referenced anove and nave decimined the arrived medicate devices marketed in interstate for use stated in the enclosure for regary mancess promote and one of the Local Drug commerce prior to May 20, 1970, the chance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisel opplication (PMA devices that have been reclassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provinces of the Act. This and Cosmetic Act (Act) that do not require uppro rar e seneral controls provisions of the Act. The You may, meretore, market the device, sayler to me of annual registration. Ifsting of
general controls provisions of the Act include requirements mightending and general controls provisions of the received.
devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it If your device is classified (see above) mis enning regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may may be subject to such additional controlis. Existing may be found in the Code of Poderal Regeral Register in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Please be advised that FDA s issualles of a substance or alle other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a decemmation that your avres by other Federal agencies. You must or any Federal statutes and regulations administered of registration and listing ( 2 l
ess statutes act s requirements, including, but not limited to: registration and listin comply with all the Act s requirements, mename manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the clectron CTR Part 807), labeling (21 CTK Part 601), god at if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000), 1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Linda Busklein

This letter will allow you to begin marketing your device as described in your Section 510(k)
10 legal This letter will allow you to begin nakting your article appreace of your device of your device to a legally premarket notification. The PDA Inding of substantial equivalence and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the latest of the may on 10, 276, 0115 - Alama dessa note the regulation If you desire specific advice for your ac vice on our noomig nogram note the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the r contact the Office of Complance at (210) 216 on (21CFR Part 807.97). You may obtain " Misbranding by relefence to prehance notificancer the Act from the Division of Small
other general information on your responsibilities under the Act from worker (800) 638, other general information on your responsion and at its toll-free number [phone] or Manufacturers, International and Consumer Assistance arovicdrh/industry/support/index.html.

Sincerely yours.

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

K050133

510(k) Number:

Device Name:

Vascular Solutions D-Stat Dry Radial Hemostatic Band

Indications for Use:

The D-Stat Radial Hemostatic Band is applied topically and is indicated for the control The D-Stat Radial Hemootate Band 10 appentaneous catheters of tubes.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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**510(k) Number** K050133

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K050133
page 1/1

## FEB | 8 2005

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

| Common/Usual Name: | Topical Hemostatic |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Trade Name: | D-Stat® Radial Hemostatic Band |
| Classification Name: | Unclassified, Product Code FRO |
| Manufacturer: | Vascular Solutions, Inc.<br>6464 Sycamore Court<br>Minneapolis, Minnesota 55369 |
| Establishment Registration: | 2134812 |
| Contact: | Linda Busklein<br>Sr. Regulatory Affairs Associate<br>[phone] phone<br>[phone] fax |
| Performance Standards: | No performance standards have been developed under section<br>514 for this device. |
| Device Description: | The D-Stat Radial Hemostatic Band consists of a lyophilized pad<br>containing thrombin, sodium carboxymethylcellulose, and<br>calcium chloride secured to a application device consisting of an<br>adjustable retention strap, retainer, and attached pads.<br>After<br>hemostasis has been achieved, the lyophilized pad may be<br>removed from the application device, covered with a provided<br>adhesive bandage, and left in place for up to 24 hours. |
| Intended Use: | The D-Stat Radial Hemostatic Band is applied topically and is<br>indicated for the control of surface bleeding from vascular<br>access sites and percutaneous catheters or tubes. |
| Summary of Non-Clinical Testing: | Tests conducted included assessment of the ability to separate<br>the lyophilized pad from the retainer and a biocompatibility<br>assessment of new materials. |
| Predicate Devices: | Vascular Solutions D-Stat Radial Hemostatic Band (K030836)<br>Vascular Solutions D-Stat Dry Hemostatic Bandage (K030836) |
| Conclusions: | The D-Stat Radial Hemostatic Band is substantially equivalent to<br>the currently marketed D-Stat Radial Hemostatic Band and the<br>D-Stat Dry Hemostatic Bandage, based on a comparison of the<br>indications for use and the technological characteristics of the<br>device. |