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FDA 510(k)

POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6

K-Number: K061356 · 2006-07-03

ApplicantAdvanced Infusion, Inc.
Decision Date2006-07-03
Product CodeMED
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6 is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Infusion, Inc.. It received FDA 510(k) clearance on 2006-07-03 under 510(k) number K061356. The device is classified under product code MED. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6?

POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6 is a medical device that received FDA 510(k) clearance on 2006-07-03. The listed applicant is Advanced Infusion, Inc.. The 510(k) number is K061356.

When did POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6 receive FDA 510(k) clearance?

POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6 received FDA 510(k) clearance on 2006-07-03, under 510(k) number K061356.

Who is the listed applicant for POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6?

The FDA 510(k) record lists Advanced Infusion, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6?

The FDA product code for POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6 is MED.

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 Advanced Infusion, Inc. 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.

K071532ALPHA INFUSION PUMP, MODEL A200, A450K061661STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20K042246MULTI-DRIP INFUSION CATHETERK021964ALPHA INFUSION PUMP AND CATHETERSK992551ALPHA INFUSION PUMP

Related Devices (Code: MED)

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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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