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Serrated Scoring Element & Balloon Fabrication

Open

Federal

Response Deadline11/11/2026, 12:00:00 PM EST

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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This subcontract involves the fabrication of specialized serrated scoring elements and balloon components for medical device projects under the Department of Veterans Affairs. The scope of work requires the precision molding or machining of scoring elements, their integration onto balloon surfaces using medical-grade polymers, and the use of pressure testing rigs to validate burst pressure. To qualify for this engagement, the manufacturer must maintain ISO 13485 and FDA Quality System Regulation certifications. The project falls under NAICS code 339113 and is managed by the Network Contract Office 8. The final deliverable consists of finished serrated balloon components provided to prime contractors.

General Info

Fabrication of ISO 13485 certified serrated balloon components for Department of Veterans Affairs.

Agency

Department Of Veterans Affairs → 248-NETWORK Contract Office 8 (36C248)

NAICS

339113 - Surgical Appliance and Supplies Manufacturing

Place of Performance

FL

Set-Aside

NONE

Documents

This scope was carved out of 36C24827Q0117.

The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

6515--Serranator PTA Serration Balloon Catheters

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Timeline

PostedNov 5

subcontract

Response DeadlineNov 11

Submission deadline

Response Deadline

11/11/2026, 12:00:00 PM ESTin 5 days

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → 248-NETWORK Contract Office 8 (36C248)

ContactsNo contacts available

OfficeN/A

Organization / AgencyDepartment Of Veterans Affairs → 248-NETWORK Contract Office 8 (36C248)

Office AddressN/A

ContactsNo contact information available

Full Description

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Manufactures specialized balloon components for prime contractors on Department of Veterans Affairs medical device projects. Performs precision molding or machining of serrated scoring elements and integrates them onto the balloon surface. Utilizes medical-grade polymers and pressure testing rigs for burst pressure validation. Requires ISO 13485 and FDA Quality System Regulation (QSR) certifications. Delivers finished serrated balloon components.

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