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FDA 510(k)

VACUUM CUP (004SD)

K-Number: K963287 · 1996-10-28

ApplicantSwift Delivery Products
Decision Date1996-10-28
Product CodeHDB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VACUUM CUP (004SD) is the device name listed in this FDA 510(k) record. The listed applicant is Swift Delivery Products. It received FDA 510(k) clearance on 1996-10-28 under 510(k) number K963287. The device is classified under product code HDB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VACUUM CUP (004SD)?

VACUUM CUP (004SD) is a medical device that received FDA 510(k) clearance on 1996-10-28. The listed applicant is Swift Delivery Products. The 510(k) number is K963287.

When did VACUUM CUP (004SD) receive FDA 510(k) clearance?

VACUUM CUP (004SD) received FDA 510(k) clearance on 1996-10-28, under 510(k) number K963287.

Who is the listed applicant for VACUUM CUP (004SD)?

The FDA 510(k) record lists Swift Delivery Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VACUUM CUP (004SD)?

The FDA product code for VACUUM CUP (004SD) is HDB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Swift Delivery Products as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K013460SWIFT LOW PROFILE CUP (PRO CUP)K973942SWIFT DELIVERY PRODUCT #300

Related Devices (Code: HDB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250298Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)Clinical Innovations, LLCK041579MEDELA SINGLE USE SILC CUP, MODEL 077.0791Medela AGK043614VACULINK, MODEL VCL 3000Medevco, Inc.K021193FORTUNE SILICONE VACUUM SUCTION, MODEL #1300Fortune Medical Instrument Corp.K020447MITYVAC MERLIN, MODEL 10027Prism Enterprises, Inc.K013460SWIFT LOW PROFILE CUP (PRO CUP)Swift Delivery Products

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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