← Product Code [DXC](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC) · K955270

# TAPE & BANDAGE, ADHESIVE (K955270)

_Robert R. Stevens · DXC · Aug 8, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC/K955270

## Device Facts

- **Applicant:** Robert R. Stevens
- **Product Code:** [DXC](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC.md)
- **Decision Date:** Aug 8, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4450
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Therapeutic

## Indications for Use

Cutaneous Compression Device for General Hospital Use.

## Device Story

Cutaneous compression device; used in general hospital settings; provides compression to skin surface; intended for general hospital use; operated by healthcare personnel; aids in management of cutaneous compression needs.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Class I adhesive tape and bandage device; mechanical compression function; no specific materials or standards cited.

## Regulatory Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

## Predicate Devices

- Cutaneous Compression Device for Hemodialysis ([K951973](/device/K951973.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.
>
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K955270

AUG 8 1996

# X. Summary of Safety and Effectiveness

**Classification Name:** Tape and Bandage, Adhesive
21 C.F.R. § 880.5240 (1994).

**Common/Usual Name:** Cutaneous Compression Device for General Hospital Use.

**Proprietary Name:** At present, no proprietary name has been chosen for this device.

**Establishment Registration:** Mr. Robert R. Stevens has not yet engaged in activities requiring establishment registration. Upon engaging in such activities, an establishment registration will be filed in accordance with the requirements set forth at 21 C.F.R. § 807.20 (1994).

**Classification:** Under Section 513 of the Federal Food, Drug, and Cosmetic Act, this device is classified into Class I.

**Performance Standards:** As of the date of this Premarket Notification submission, no Performance Standards have been established for this device under Section 514 of the Federal Food, Drug, and Cosmetic Act. As such, no actions have been taken to comply with Section 514 Performance Standards.

**Labeling/Promotional Materials:** Proposed labeling is included in this submission.

**Substantial Equivalence:** This device is substantially equivalent to the following legally-marketed device ("Predicate Device") in terms of safety, effectiveness, and intended use:
**Product:** Cutaneous Compression Device for Hemodialysis
**Manufacturer:** Mr. Robert R. Stevens
510(k) Number: K951973
Substantial Equivalence Date: Class I exempt.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC/K955270](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC/K955270)

**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).

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