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FDA 510(k)

SWIFT LOW PROFILE CUP (PRO CUP)

K-Number: K013460 · 2002-01-17

ApplicantSwift Delivery Products
Decision Date2002-01-17
Product CodeHDB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SWIFT LOW PROFILE CUP (PRO CUP) 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 2002-01-17 under 510(k) number K013460. 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 SWIFT LOW PROFILE CUP (PRO CUP)?

SWIFT LOW PROFILE CUP (PRO CUP) is a medical device that received FDA 510(k) clearance on 2002-01-17. The listed applicant is Swift Delivery Products. The 510(k) number is K013460.

When did SWIFT LOW PROFILE CUP (PRO CUP) receive FDA 510(k) clearance?

SWIFT LOW PROFILE CUP (PRO CUP) received FDA 510(k) clearance on 2002-01-17, under 510(k) number K013460.

Who is the listed applicant for SWIFT LOW PROFILE CUP (PRO CUP)?

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 SWIFT LOW PROFILE CUP (PRO CUP)?

The FDA product code for SWIFT LOW PROFILE CUP (PRO CUP) 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.

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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.

K973942SWIFT DELIVERY PRODUCT #300K963287VACUUM CUP (004SD)

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.K011532MITYVACPrism Enterprises, Inc.

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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