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FDA 510(k)

PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF.

K-Number: K881493 · 1988-05-20

ApplicantPharmacia Deltec, Inc.
Decision Date1988-05-20
Product CodeLKG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia Deltec, Inc.. It received FDA 510(k) clearance on 1988-05-20 under 510(k) number K881493. The device is classified under product code LKG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF.?

PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. is a medical device that received FDA 510(k) clearance on 1988-05-20. The listed applicant is Pharmacia Deltec, Inc.. The 510(k) number is K881493.

When did PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. receive FDA 510(k) clearance?

PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. received FDA 510(k) clearance on 1988-05-20, under 510(k) number K881493.

Who is the listed applicant for PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF.?

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

What is the FDA product code for PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF.?

The FDA product code for PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. is LKG.

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Other records listing Pharmacia Deltec, 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.

K943310MODEL 6100 AMBULATORY INFUSION SYSTEMK942046PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVEK942161LOCKBOXK942024PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEMK941445EXTENSION SET WITH ANTI-SIPHON VALVEK931073CATH-FINDER

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Related Devices (Code: LKG)

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.

K950315CORDIS CSF RESERVOIRCordis Corp.K881690PORT-A-CATH PORTAL INTRODUCER FORCEPSPharmacia Deltec, Inc.K874498CSF-VENTRICULOSTOMY RESERVOIRPudenz-Schulte Medical Research Corp.K874468P-S MEDICAL VENTRICULAR ACCESS PORTPudenz-Schulte Medical Research Corp.K833822P-S MEDICAL CSF ACCESS DEV 15MM/25MMPudenz-Schulte Medical Research Corp.K833672HH SUBCUTANEOUS ACCESS PORTHolter-Hausner Intl.

Official Source

View on FDA Database →

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

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